Trial Outcomes & Findings for A Global Study to Assess the Effects of MEDI4736 (Durvalumab), Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer (NCT NCT02352948)

NCT ID: NCT02352948

Last Updated: 2024-07-26

Results Overview

The OS was defined as the time from the date of randomization until death due to any cause.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

597 participants

Primary outcome timeframe

From randomization (Day 1) until death due to any cause, approximately 36 months

Results posted on

2024-07-26

Participant Flow

This study was divided into 2 parts, sub-study A (82 centers across Europe, Asia, and North America) and sub-study B (149 centers across Europe, Asia, North America, and South America) conducted between 13 January 2015 and 09 February 2018 (data cut-off date).

The study had a pre-screening period to determine the programmed cell death ligand 1 (PD-L1) status, followed by a screening period and 12 month treatment period. A total of 595 participants were randomized to either sub-study A \[PD-L1 high (\>=25% of tumor cell (TC) expressing PD-L1)\] or sub-study B \[PD-L1 low/neg (\<25% of TC expressing PD-L1)\].

Participant milestones

Participant milestones
Measure
Sub-study A: Durvalumab
Participants received durvalumab (MEDI4736) 10 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks (Q2W) for 12 months (up to 26 doses).
Sub-study A: Standard of Care (SoC)
Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/meter square (m\^2) IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m\^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until progression of disease (PD), initiation of alternative anti-cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
Sub-study B: Durvalumab+Tremelimumab
Participants received durvalumab 20 mg/kg plus tremelimumab 1 mg/kg IV infusion every 4 weeks (Q4W) for 12 weeks (4 doses) followed by durvalumab alone 10 mg/kg IV infusion Q2W for 34 weeks starting at Week 16 (up to 18 additional doses).
Sub-study B: SoC
Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m\^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anti-cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
Sub-study B: Durvalumab
Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
Sub-study B: Tremelimumab
Participants received tremelimumab 10 mg/kg IV infusion Q4W for 24 weeks followed by every 12 weeks (Q12W) for 24 weeks (up to 9 doses).
Overall Study
STARTED
62
64
174
118
117
60
Overall Study
Received Treatment
62
63
173
110
117
60
Overall Study
Completed Study Treatment
15
0
36
0
23
4
Overall Study
COMPLETED
13
5
45
19
29
11
Overall Study
NOT COMPLETED
49
59
129
99
88
49

Reasons for withdrawal

Reasons for withdrawal
Measure
Sub-study A: Durvalumab
Participants received durvalumab (MEDI4736) 10 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks (Q2W) for 12 months (up to 26 doses).
Sub-study A: Standard of Care (SoC)
Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/meter square (m\^2) IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m\^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until progression of disease (PD), initiation of alternative anti-cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
Sub-study B: Durvalumab+Tremelimumab
Participants received durvalumab 20 mg/kg plus tremelimumab 1 mg/kg IV infusion every 4 weeks (Q4W) for 12 weeks (4 doses) followed by durvalumab alone 10 mg/kg IV infusion Q2W for 34 weeks starting at Week 16 (up to 18 additional doses).
Sub-study B: SoC
Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m\^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anti-cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
Sub-study B: Durvalumab
Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
Sub-study B: Tremelimumab
Participants received tremelimumab 10 mg/kg IV infusion Q4W for 24 weeks followed by every 12 weeks (Q12W) for 24 weeks (up to 9 doses).
Overall Study
Death
47
48
114
74
77
44
Overall Study
Lost to Follow-up
1
0
2
1
2
1
Overall Study
Withdrawal by Subject
1
10
11
23
9
4
Overall Study
Eligibility criteria not fulfilled
0
1
0
1
0
0
Overall Study
Other
0
0
2
0
0
0

Baseline Characteristics

A Global Study to Assess the Effects of MEDI4736 (Durvalumab), Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Sub-study A: Durvalumab
n=62 Participants
Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
Sub-study A: SoC
n=64 Participants
Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m\^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anti-cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
Sub-study B: Durvalumab+Tremelimumab
n=174 Participants
Participants received durvalumab 20 mg/kg plus tremelimumab 1 mg/kg IV infusion Q4W for 12 weeks (4 doses) followed by durvalumab alone 10 mg/kg IV infusion Q2W for 34 weeks starting at Week 16 (up to 18 additional doses).
Sub-study B: SoC
n=118 Participants
Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m\^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anti-cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
Sub-study B: Durvalumab
n=117 Participants
Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
Sub-study B: Tremelimumab
n=60 Participants
Participants received tremelimumab 10 mg/kg IV infusion Q4W for 24 weeks followed by Q12W for 24 weeks (up to 9 doses).
Total
n=595 Participants
Total of all reporting groups
Age, Customized
<50 years
3 Participants
n=5 Participants
11 Participants
n=7 Participants
16 Participants
n=5 Participants
8 Participants
n=4 Participants
13 Participants
n=21 Participants
4 Participants
n=8 Participants
55 Participants
n=8 Participants
Age, Customized
>=50 to <65 years
31 Participants
n=5 Participants
25 Participants
n=7 Participants
79 Participants
n=5 Participants
49 Participants
n=4 Participants
52 Participants
n=21 Participants
27 Participants
n=8 Participants
263 Participants
n=8 Participants
Age, Customized
>=65 to <75 years
24 Participants
n=5 Participants
21 Participants
n=7 Participants
64 Participants
n=5 Participants
50 Participants
n=4 Participants
39 Participants
n=21 Participants
24 Participants
n=8 Participants
222 Participants
n=8 Participants
Age, Customized
>=75 years
4 Participants
n=5 Participants
7 Participants
n=7 Participants
15 Participants
n=5 Participants
11 Participants
n=4 Participants
13 Participants
n=21 Participants
5 Participants
n=8 Participants
55 Participants
n=8 Participants
Sex: Female, Male
Female
20 Participants
n=5 Participants
16 Participants
n=7 Participants
59 Participants
n=5 Participants
37 Participants
n=4 Participants
44 Participants
n=21 Participants
21 Participants
n=8 Participants
197 Participants
n=8 Participants
Sex: Female, Male
Male
42 Participants
n=5 Participants
48 Participants
n=7 Participants
115 Participants
n=5 Participants
81 Participants
n=4 Participants
73 Participants
n=21 Participants
39 Participants
n=8 Participants
398 Participants
n=8 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
Race/Ethnicity, Customized
Asian
22 Participants
n=5 Participants
23 Participants
n=7 Participants
41 Participants
n=5 Participants
41 Participants
n=4 Participants
34 Participants
n=21 Participants
16 Participants
n=8 Participants
177 Participants
n=8 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
Race/Ethnicity, Customized
Black or African American
0 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
2 Participants
n=4 Participants
2 Participants
n=21 Participants
1 Participants
n=8 Participants
9 Participants
n=8 Participants
Race/Ethnicity, Customized
White
40 Participants
n=5 Participants
40 Participants
n=7 Participants
129 Participants
n=5 Participants
74 Participants
n=4 Participants
79 Participants
n=21 Participants
43 Participants
n=8 Participants
405 Participants
n=8 Participants
Race/Ethnicity, Customized
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
0 Participants
n=8 Participants
1 Participants
n=8 Participants
Race/Ethnicity, Customized
Other
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
1 Participants
n=21 Participants
0 Participants
n=8 Participants
3 Participants
n=8 Participants

PRIMARY outcome

Timeframe: From randomization (Day 1) until death due to any cause, approximately 36 months

Population: Sub-study A and B: FAS included all randomized participants analyzed on an ITT basis.

The OS was defined as the time from the date of randomization until death due to any cause.

Outcome measures

Outcome measures
Measure
Sub-study A: Durvalumab
n=62 Participants
Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
Sub-study A: SoC
n=64 Participants
Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m\^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anti-cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
Sub-study B: Durvalumab+Tremelimumab
n=174 Participants
Participants received durvalumab 20 mg/kg plus tremelimumab 1 mg/kg IV infusion Q4W for 12 weeks (4 doses) followed by durvalumab alone 10 mg/kg IV infusion Q2W for 34 weeks starting at Week 16 (up to 18 additional doses).
Sub-study B: SoC
n=118 Participants
Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m\^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anti-cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
Sub-study B: Durvalumab
Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
Sub-study B: Tremelimumab
Participants received tremelimumab 10 mg/kg IV infusion Q4W for 24 weeks followed by Q12W for 24 weeks (up to 9 doses).
Overall Survival (OS)
11.7 months
Interval 8.2 to 17.4
6.8 months
Interval 4.9 to 10.2
11.5 months
Interval 8.7 to 14.1
8.7 months
Interval 6.5 to 11.7

PRIMARY outcome

Timeframe: Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years.

Population: Sub-study A and B: FAS included all randomized participants analyzed on an ITT basis.

The PFS was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy prior to progression. The PFS was determined by Investigator assessments according to response evaluation criteria in solid tumours (RECIST) version 1.1. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion

Outcome measures

Outcome measures
Measure
Sub-study A: Durvalumab
n=62 Participants
Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
Sub-study A: SoC
n=64 Participants
Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m\^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anti-cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
Sub-study B: Durvalumab+Tremelimumab
n=174 Participants
Participants received durvalumab 20 mg/kg plus tremelimumab 1 mg/kg IV infusion Q4W for 12 weeks (4 doses) followed by durvalumab alone 10 mg/kg IV infusion Q2W for 34 weeks starting at Week 16 (up to 18 additional doses).
Sub-study B: SoC
n=118 Participants
Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m\^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anti-cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
Sub-study B: Durvalumab
Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
Sub-study B: Tremelimumab
Participants received tremelimumab 10 mg/kg IV infusion Q4W for 24 weeks followed by Q12W for 24 weeks (up to 9 doses).
Progression-Free Survival (PFS)
3.8 months
Interval 1.9 to 5.6
2.2 months
Interval 1.9 to 3.7
3.5 months
Interval 2.3 to 4.6
3.5 months
Interval 1.9 to 3.9

SECONDARY outcome

Timeframe: From randomization (Day 1) until death due to any cause, approximately 36 months

Population: FAS included all randomized participants analyzed on an ITT basis.

The OS was defined as the time from the date of randomization until death due to any cause.

Outcome measures

Outcome measures
Measure
Sub-study A: Durvalumab
n=174 Participants
Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
Sub-study A: SoC
n=117 Participants
Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m\^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anti-cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
Sub-study B: Durvalumab+Tremelimumab
n=60 Participants
Participants received durvalumab 20 mg/kg plus tremelimumab 1 mg/kg IV infusion Q4W for 12 weeks (4 doses) followed by durvalumab alone 10 mg/kg IV infusion Q2W for 34 weeks starting at Week 16 (up to 18 additional doses).
Sub-study B: SoC
Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m\^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anti-cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
Sub-study B: Durvalumab
Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
Sub-study B: Tremelimumab
Participants received tremelimumab 10 mg/kg IV infusion Q4W for 24 weeks followed by Q12W for 24 weeks (up to 9 doses).
OS, Contribution of the Components Analysis of Sub-study B
11.5 months
Interval 8.7 to 14.1
10.0 months
Interval 7.1 to 13.2
6.9 months
Interval 3.9 to 13.2

SECONDARY outcome

Timeframe: From randomization (Day 1) up to 12 months

Population: Sub-study A and B: FAS included all randomized participants analyzed on an ITT basis.

The OS12 was defined as the percentage of participants who were alive at 12 months after randomisation per Kaplan-Meier estimate of OS at 12 months.

Outcome measures

Outcome measures
Measure
Sub-study A: Durvalumab
n=62 Participants
Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
Sub-study A: SoC
n=64 Participants
Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m\^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anti-cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
Sub-study B: Durvalumab+Tremelimumab
n=174 Participants
Participants received durvalumab 20 mg/kg plus tremelimumab 1 mg/kg IV infusion Q4W for 12 weeks (4 doses) followed by durvalumab alone 10 mg/kg IV infusion Q2W for 34 weeks starting at Week 16 (up to 18 additional doses).
Sub-study B: SoC
n=118 Participants
Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m\^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anti-cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
Sub-study B: Durvalumab
n=117 Participants
Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
Sub-study B: Tremelimumab
n=60 Participants
Participants received tremelimumab 10 mg/kg IV infusion Q4W for 24 weeks followed by Q12W for 24 weeks (up to 9 doses).
Percentage of Participants Alive at 12 Months (OS12)
49.3 percentage of participants
Interval 36.3 to 61.0
31.3 percentage of participants
Interval 20.2 to 43.0
49.5 percentage of participants
Interval 41.7 to 56.7
38.8 percentage of participants
Interval 29.9 to 47.7
43.6 percentage of participants
Interval 34.4 to 52.4
41.2 percentage of participants
Interval 28.7 to 53.3

SECONDARY outcome

Timeframe: Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years.

Population: FAS included all randomized participants analyzed on an ITT basis.

The PFS was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy prior to progression. The PFS was determined by Investigator assessments according to RECIST v1.1. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion

Outcome measures

Outcome measures
Measure
Sub-study A: Durvalumab
n=174 Participants
Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
Sub-study A: SoC
n=117 Participants
Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m\^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anti-cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
Sub-study B: Durvalumab+Tremelimumab
n=60 Participants
Participants received durvalumab 20 mg/kg plus tremelimumab 1 mg/kg IV infusion Q4W for 12 weeks (4 doses) followed by durvalumab alone 10 mg/kg IV infusion Q2W for 34 weeks starting at Week 16 (up to 18 additional doses).
Sub-study B: SoC
Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m\^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anti-cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
Sub-study B: Durvalumab
Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
Sub-study B: Tremelimumab
Participants received tremelimumab 10 mg/kg IV infusion Q4W for 24 weeks followed by Q12W for 24 weeks (up to 9 doses).
PFS, Contribution of the Components Analysis of Sub-study B
3.5 months
Interval 2.3 to 4.6
3.1 months
Interval 1.9 to 3.7
2.1 months
Interval 1.8 to 3.2

SECONDARY outcome

Timeframe: Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years.

Population: Sub-study A and B: FAS included all randomized participants with measureable disease at baseline analyzed on an ITT basis.

The ORR was defined as the percentage of participants with at least 1 visit response of complete response (CR) or partial response (PR) among ITT participants who had measurable disease at baseline. CR was defined as disappearance of all target lesions (any pathological lymph nodes selected as target lesions must have a reduction in short axis to \<10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum of diameters as long as criteria for PD are not met). The ORR was measured using Investigator assessments according to RECIST v1.1.

Outcome measures

Outcome measures
Measure
Sub-study A: Durvalumab
n=62 Participants
Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
Sub-study A: SoC
n=64 Participants
Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m\^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anti-cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
Sub-study B: Durvalumab+Tremelimumab
n=174 Participants
Participants received durvalumab 20 mg/kg plus tremelimumab 1 mg/kg IV infusion Q4W for 12 weeks (4 doses) followed by durvalumab alone 10 mg/kg IV infusion Q2W for 34 weeks starting at Week 16 (up to 18 additional doses).
Sub-study B: SoC
n=118 Participants
Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m\^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anti-cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
Sub-study B: Durvalumab
n=117 Participants
Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
Sub-study B: Tremelimumab
n=60 Participants
Participants received tremelimumab 10 mg/kg IV infusion Q4W for 24 weeks followed by Q12W for 24 weeks (up to 9 doses).
Objective Response Rate (ORR)
35.5 percentage of participants
12.5 percentage of participants
14.9 percentage of participants
6.8 percentage of participants
15.4 percentage of participants
6.7 percentage of participants

SECONDARY outcome

Timeframe: Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years.

Population: Sub-study A and B: FAS included all randomized participants with measureable disease at baseline analyzed on an ITT basis. Only participants with objective response were analyzed.

The DoR was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression. The DoR was determined by Investigator assessments according to RECIST v1.1. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion

Outcome measures

Outcome measures
Measure
Sub-study A: Durvalumab
n=62 Participants
Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
Sub-study A: SoC
n=64 Participants
Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m\^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anti-cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
Sub-study B: Durvalumab+Tremelimumab
n=174 Participants
Participants received durvalumab 20 mg/kg plus tremelimumab 1 mg/kg IV infusion Q4W for 12 weeks (4 doses) followed by durvalumab alone 10 mg/kg IV infusion Q2W for 34 weeks starting at Week 16 (up to 18 additional doses).
Sub-study B: SoC
n=118 Participants
Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m\^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anti-cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
Sub-study B: Durvalumab
n=117 Participants
Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
Sub-study B: Tremelimumab
n=60 Participants
Participants received tremelimumab 10 mg/kg IV infusion Q4W for 24 weeks followed by Q12W for 24 weeks (up to 9 doses).
Duration of Response (DoR)
9.5 months
Interval 3.0 to 17.8
4.8 months
Interval 1.9 to 7.6
12.2 months
Interval 6.5 to
The upper limit of the 75th percentile was not calculated as it was not reached.
10.8 months
Interval 5.6 to 12.2
10.0 months
Interval 4.0 to
The upper limit of the 75th percentile was not calculated as it was not reached.
4.7 months
Interval 2.9 to
The upper limit of the 75th percentile was not calculated as it was not reached.

SECONDARY outcome

Timeframe: Tumour scans performed at baseline then every ~8 weeks up to 6 months

Population: Sub-study A and B: FAS included all randomized participants analyzed on an ITT basis.

The APF6 was defined as the percentage of participants who were alive and progression free per RECIST v1.1 at 6 months after randomization per Kaplan-Meier estimate of PFS at 6 months. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion

Outcome measures

Outcome measures
Measure
Sub-study A: Durvalumab
n=62 Participants
Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
Sub-study A: SoC
n=64 Participants
Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m\^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anti-cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
Sub-study B: Durvalumab+Tremelimumab
n=174 Participants
Participants received durvalumab 20 mg/kg plus tremelimumab 1 mg/kg IV infusion Q4W for 12 weeks (4 doses) followed by durvalumab alone 10 mg/kg IV infusion Q2W for 34 weeks starting at Week 16 (up to 18 additional doses).
Sub-study B: SoC
n=118 Participants
Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m\^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anti-cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
Sub-study B: Durvalumab
n=117 Participants
Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
Sub-study B: Tremelimumab
n=60 Participants
Participants received tremelimumab 10 mg/kg IV infusion Q4W for 24 weeks followed by Q12W for 24 weeks (up to 9 doses).
Percentage of Participants Alive and Progression Free at 6 Months (APF6)
35.5 percentage of participants
Interval 23.9 to 47.3
24.1 percentage of participants
Interval 14.1 to 35.6
31.5 percentage of participants
Interval 24.6 to 38.7
27.6 percentage of participants
Interval 19.0 to 36.7
27.2 percentage of participants
Interval 19.4 to 35.6
14.5 percentage of participants
Interval 6.9 to 24.9

SECONDARY outcome

Timeframe: Tumour scans performed at baseline then every ~8 weeks up to 12 months.

Population: Sub-study A and B: FAS included all randomized participants analyzed on an ITT basis.

The APF12 was defined as the percentage of participants who were alive and progression free per RECIST v1.1 at 12 months after randomization per Kaplan-Meier estimate of PFS at 12 months. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion

Outcome measures

Outcome measures
Measure
Sub-study A: Durvalumab
n=62 Participants
Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
Sub-study A: SoC
n=64 Participants
Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m\^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anti-cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
Sub-study B: Durvalumab+Tremelimumab
n=174 Participants
Participants received durvalumab 20 mg/kg plus tremelimumab 1 mg/kg IV infusion Q4W for 12 weeks (4 doses) followed by durvalumab alone 10 mg/kg IV infusion Q2W for 34 weeks starting at Week 16 (up to 18 additional doses).
Sub-study B: SoC
n=118 Participants
Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m\^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anti-cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
Sub-study B: Durvalumab
n=117 Participants
Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
Sub-study B: Tremelimumab
n=60 Participants
Participants received tremelimumab 10 mg/kg IV infusion Q4W for 24 weeks followed by Q12W for 24 weeks (up to 9 doses).
Percentage of Participants Alive and Progression Free at 12 Months (APF12)
19.4 percentage of participants
Interval 10.7 to 30.0
9.9 percentage of participants
Interval 3.8 to 19.3
20.6 percentage of participants
Interval 14.7 to 27.1
8.0 percentage of participants
Interval 3.4 to 15.2
15.0 percentage of participants
Interval 9.1 to 22.3
7.3 percentage of participants
Interval 2.4 to 16.0

SECONDARY outcome

Timeframe: Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until first progression. Disease then assessed per local practice until 2nd progression. Assessed up to a maximum of approximately 3 years.

Population: FAS included all randomized participants analyzed on an ITT basis.

The PFS2 was defined as the time from the date of randomization to the earliest of the progression event subsequent to that used for the PFS endpoint or death and determined by local standard clinical practice and have included any of the following: objective radiological, symptomatic progression, or death. PFS2 was reported for sub-study B only.

Outcome measures

Outcome measures
Measure
Sub-study A: Durvalumab
n=174 Participants
Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
Sub-study A: SoC
n=118 Participants
Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m\^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anti-cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
Sub-study B: Durvalumab+Tremelimumab
n=117 Participants
Participants received durvalumab 20 mg/kg plus tremelimumab 1 mg/kg IV infusion Q4W for 12 weeks (4 doses) followed by durvalumab alone 10 mg/kg IV infusion Q2W for 34 weeks starting at Week 16 (up to 18 additional doses).
Sub-study B: SoC
n=60 Participants
Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m\^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anti-cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
Sub-study B: Durvalumab
Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
Sub-study B: Tremelimumab
Participants received tremelimumab 10 mg/kg IV infusion Q4W for 24 weeks followed by Q12W for 24 weeks (up to 9 doses).
Time From Randomisation to Second Progression (PFS2) of Sub-study B
9.1 months
Interval 6.6 to 12.3
6.7 months
Interval 4.7 to 8.9
8.0 months
Interval 6.3 to 10.0
5.7 months
Interval 3.2 to 10.0

Adverse Events

Sub-study A: Durvalumab

Serious events: 23 serious events
Other events: 52 other events
Deaths: 48 deaths

Sub-study A: SoC

Serious events: 16 serious events
Other events: 59 other events
Deaths: 55 deaths

Sub-study B: Durvalumab+Tremelimumab

Serious events: 65 serious events
Other events: 139 other events
Deaths: 118 deaths

Sub-study B: SoC

Serious events: 28 serious events
Other events: 100 other events
Deaths: 90 deaths

Sub-study B: Durvalumab

Serious events: 36 serious events
Other events: 99 other events
Deaths: 83 deaths

Sub-study B: Tremelimumab

Serious events: 23 serious events
Other events: 48 other events
Deaths: 46 deaths

Serious adverse events

Serious adverse events
Measure
Sub-study A: Durvalumab
n=62 participants at risk
Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
Sub-study A: SoC
n=63 participants at risk
Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m\^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
Sub-study B: Durvalumab+Tremelimumab
n=173 participants at risk
Participants received durvalumab 20 mg/kg plus tremelimumab 1 mg/kg IV infusion Q4W for 12 weeks (4 doses) followed by durvalumab alone 10 mg/kg IV infusion Q2W for 34 weeks starting at Week 16 (up to 18 additional doses).
Sub-study B: SoC
n=110 participants at risk
Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m\^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
Sub-study B: Durvalumab
n=117 participants at risk
Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
Sub-study B: Tremelimumab
n=60 participants at risk
Participants received tremelimumab 10 mg/kg IV infusion Q4W for 24 weeks followed by Q12W for 24 weeks (up to 9 doses).
Infections and infestations
Pneumonia
6.5%
4/62 • Number of events 5 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
4.8%
3/63 • Number of events 3 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
4.0%
7/173 • Number of events 7 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.8%
2/110 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
2/117 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
3.3%
2/60 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Infections and infestations
Pulmonary sepsis
1.6%
1/62 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.6%
1/63 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Infections and infestations
Pyelonephritis
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.6%
1/63 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Infections and infestations
Respiratory tract infection
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.91%
1/110 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Infections and infestations
Sepsis
3.2%
2/62 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Infections and infestations
Varicella zoster virus infection
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
1/60 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Injury, poisoning and procedural complications
Clavicle fracture
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Injury, poisoning and procedural complications
Femur fracture
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Injury, poisoning and procedural complications
Fractured ischium
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Injury, poisoning and procedural complications
Head injury
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Injury, poisoning and procedural complications
Humerus fracture
1.6%
1/62 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Injury, poisoning and procedural complications
Overdose
1.6%
1/62 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Investigations
Amylase increased
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Investigations
Blood creatinine increased
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Investigations
C-reactive protein increased
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Investigations
Transaminases increased
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.91%
1/110 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Metabolism and nutrition disorders
Dehydration
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Blood and lymphatic system disorders
Anaemia
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
3.2%
2/63 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.91%
1/110 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Blood and lymphatic system disorders
Febrile neutropenia
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
7.9%
5/63 • Number of events 5 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Blood and lymphatic system disorders
Neutropenia
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.91%
1/110 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Blood and lymphatic system disorders
Pancytopenia
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.91%
1/110 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Cardiac disorders
Acute myocardial infarction
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.6%
1/63 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.91%
1/110 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Cardiac disorders
Angina pectoris
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.6%
1/63 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Cardiac disorders
Atrial fibrillation
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.91%
1/110 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Cardiac disorders
Myocardial infarction
1.6%
1/62 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Cardiac disorders
Pericarditis
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Cardiac disorders
Cardiac arrest
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.91%
1/110 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Cardiac disorders
Cardiac failure
1.6%
1/62 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.2%
2/173 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Cardiac disorders
Cardiac failure congestive
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Cardiac disorders
Tachycardia
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Endocrine disorders
Adrenal insufficiency
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Endocrine disorders
Glucocorticoid deficiency
1.6%
1/62 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Endocrine disorders
Hypopituitarism
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Endocrine disorders
Inappropriate antidiuretic hormone secretion
1.6%
1/62 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Endocrine disorders
Thyroiditis
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Gastrointestinal disorders
Abdominal pain
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.91%
1/110 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Gastrointestinal disorders
Ascites
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
1/60 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Gastrointestinal disorders
Colitis
1.6%
1/62 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
3/173 • Number of events 4 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
8.3%
5/60 • Number of events 5 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Gastrointestinal disorders
Diarrhoea
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
3/173 • Number of events 4 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
11.7%
7/60 • Number of events 8 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Gastrointestinal disorders
Dysphagia
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.91%
1/110 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Gastrointestinal disorders
Enterocolitis
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.91%
1/110 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Gastrointestinal disorders
Gastrointestinal toxicity
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
1/60 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Gastrointestinal disorders
Ileus paralytic
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.91%
1/110 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Gastrointestinal disorders
Pancreatitis
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Gastrointestinal disorders
Small intestinal obstruction
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Gastrointestinal disorders
Subileus
1.6%
1/62 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Gastrointestinal disorders
Vomiting
1.6%
1/62 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
3/173 • Number of events 3 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.91%
1/110 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
General disorders
Asthenia
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
General disorders
Death
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
General disorders
Fatigue
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.6%
1/63 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.91%
1/110 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
General disorders
General physical health deterioration
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.6%
1/63 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
General disorders
Hyperthermia
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
General disorders
Non-cardiac chest pain
1.6%
1/62 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
General disorders
Oedema peripheral
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
General disorders
Pain
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
General disorders
Perforation
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
General disorders
Pyrexia
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.91%
1/110 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
2/117 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
General disorders
Sudden cardiac death
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.2%
2/173 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.91%
1/110 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
2/117 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Hepatobiliary disorders
Autoimmune hepatitis
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
3/173 • Number of events 3 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Hepatobiliary disorders
Cholangitis
1.6%
1/62 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Hepatobiliary disorders
Cholestasis
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Hepatobiliary disorders
Drug-induced liver injury
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Hepatobiliary disorders
Hepatitis
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Immune system disorders
Cytokine release syndrome
1.6%
1/62 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Infections and infestations
Appendicitis
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.91%
1/110 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Infections and infestations
Bacterial sepsis
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Infections and infestations
Bronchitis
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
1/60 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Infections and infestations
Bronchitis viral
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Infections and infestations
Campylobacter gastroenteritis
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Infections and infestations
Clostridium difficile colitis
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
3.3%
2/60 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Infections and infestations
Escherichia infection
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Infections and infestations
Gastroenteritis
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Infections and infestations
Infection
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Infections and infestations
Pneumocystis jirovecii pneumonia
1.6%
1/62 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Infections and infestations
Infectious pleural effusion
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
1/60 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Infections and infestations
Influenza
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Infections and infestations
Lower respiratory tract infection
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.6%
1/63 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.91%
1/110 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Metabolism and nutrition disorders
Hypercalcaemia
1.6%
1/62 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Metabolism and nutrition disorders
Hyperglycaemia
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.2%
2/173 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
2/117 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Musculoskeletal and connective tissue disorders
Muscular weakness
1.6%
1/62 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.91%
1/110 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
1/60 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.6%
1/63 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Nervous system disorders
Cerebrovascular accident
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.6%
1/63 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Nervous system disorders
Vocal cord paralysis
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Renal and urinary disorders
Urinary retention
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.6%
1/63 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
1.6%
1/62 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
4.0%
7/173 • Number of events 7 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.8%
2/110 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
2/117 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Respiratory, thoracic and mediastinal disorders
Pneumothorax
1.6%
1/62 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.6%
1/63 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.2%
2/173 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
2/117 • Number of events 3 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
1/60 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
1/60 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
3.2%
2/62 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
2.9%
5/173 • Number of events 5 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.91%
1/110 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
1/60 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Vascular disorders
Orthostatic hypotension
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.6%
1/63 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis carcinomatosa
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.91%
1/110 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage IV
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour necrosis
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Nervous system disorders
Brain oedema
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
1/60 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Vascular disorders
Hypotension
1.6%
1/62 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.91%
1/110 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Nervous system disorders
Cerebral infarction
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Nervous system disorders
Dizziness
1.6%
1/62 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Nervous system disorders
Epilepsy
1.6%
1/62 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Nervous system disorders
Ischaemic stroke
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.91%
1/110 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Nervous system disorders
Seizure
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
1/60 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Nervous system disorders
Syncope
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.6%
1/63 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Nervous system disorders
Transient ischaemic attack
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Product Issues
Device dislocation
1.6%
1/62 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Psychiatric disorders
Mental status changes
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Renal and urinary disorders
Acute kidney injury
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Renal and urinary disorders
Haematuria
1.6%
1/62 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Renal and urinary disorders
Renal failure
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.91%
1/110 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
1.6%
1/62 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.91%
1/110 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Respiratory, thoracic and mediastinal disorders
Bronchial fistula
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.6%
1/63 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.2%
2/173 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.2%
2/173 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.91%
1/110 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
3.2%
2/62 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
4.8%
3/62 • Number of events 3 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.2%
2/173 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
3.3%
2/60 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.91%
1/110 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
2.9%
5/173 • Number of events 5 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.91%
1/110 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
1.6%
1/62 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.91%
1/110 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
3.3%
2/60 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Skin and subcutaneous tissue disorders
Rash
1.6%
1/62 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Skin and subcutaneous tissue disorders
Toxic skin eruption
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Vascular disorders
Deep vein thrombosis
1.6%
1/62 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Vascular disorders
Embolism
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Vascular disorders
Internal haemorrhage
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Vascular disorders
Pelvic venous thrombosis
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Vascular disorders
Shock haemorrhagic
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Vascular disorders
Subclavian vein thrombosis
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.91%
1/110 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Vascular disorders
Superior vena cava syndrome
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.

Other adverse events

Other adverse events
Measure
Sub-study A: Durvalumab
n=62 participants at risk
Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
Sub-study A: SoC
n=63 participants at risk
Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m\^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
Sub-study B: Durvalumab+Tremelimumab
n=173 participants at risk
Participants received durvalumab 20 mg/kg plus tremelimumab 1 mg/kg IV infusion Q4W for 12 weeks (4 doses) followed by durvalumab alone 10 mg/kg IV infusion Q2W for 34 weeks starting at Week 16 (up to 18 additional doses).
Sub-study B: SoC
n=110 participants at risk
Participants received either erlotinib 150 mg tablet orally once daily; gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle; or vinorelbine 30 mg/m\^2 IV infusion on Days 1, 8, 15, and 22 of a 28-day cycle until PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment criterion occurred.
Sub-study B: Durvalumab
n=117 participants at risk
Participants received durvalumab 10 mg/kg IV infusion Q2W for 12 months (up to 26 doses).
Sub-study B: Tremelimumab
n=60 participants at risk
Participants received tremelimumab 10 mg/kg IV infusion Q4W for 24 weeks followed by Q12W for 24 weeks (up to 9 doses).
Blood and lymphatic system disorders
Anaemia
8.1%
5/62 • Number of events 5 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
27.0%
17/63 • Number of events 22 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
9.8%
17/173 • Number of events 18 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
24.5%
27/110 • Number of events 49 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
9.4%
11/117 • Number of events 13 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
8.3%
5/60 • Number of events 5 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Blood and lymphatic system disorders
Leukopenia
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
6.3%
4/63 • Number of events 8 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.2%
2/173 • Number of events 3 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
6.4%
7/110 • Number of events 15 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
1/60 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Blood and lymphatic system disorders
Neutropenia
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
11.1%
7/63 • Number of events 40 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
3/173 • Number of events 7 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
16.4%
18/110 • Number of events 48 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
1/60 • Number of events 3 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Blood and lymphatic system disorders
Thrombocytopenia
1.6%
1/62 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
7.9%
5/63 • Number of events 10 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
3/173 • Number of events 6 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
10.0%
11/110 • Number of events 15 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
3.4%
4/117 • Number of events 4 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
3.3%
2/60 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Endocrine disorders
Hyperthyroidism
3.2%
2/62 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.6%
1/63 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
9.8%
17/173 • Number of events 17 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
5.1%
6/117 • Number of events 7 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
1/60 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Endocrine disorders
Hypothyroidism
9.7%
6/62 • Number of events 6 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
8.1%
14/173 • Number of events 15 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.91%
1/110 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
8.5%
10/117 • Number of events 11 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
5.0%
3/60 • Number of events 4 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Gastrointestinal disorders
Abdominal pain
6.5%
4/62 • Number of events 4 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
6.3%
4/63 • Number of events 4 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
2.9%
5/173 • Number of events 5 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.8%
2/110 • Number of events 5 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
2/117 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
3.3%
2/60 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Gastrointestinal disorders
Abdominal pain upper
1.6%
1/62 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.6%
1/63 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.2%
2/173 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
3.6%
4/110 • Number of events 6 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
6.0%
7/117 • Number of events 7 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
3.3%
2/60 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Gastrointestinal disorders
Constipation
21.0%
13/62 • Number of events 15 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
23.8%
15/63 • Number of events 16 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
8.1%
14/173 • Number of events 15 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
10.0%
11/110 • Number of events 12 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
12.8%
15/117 • Number of events 16 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
6.7%
4/60 • Number of events 4 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Gastrointestinal disorders
Diarrhoea
14.5%
9/62 • Number of events 13 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
12.7%
8/63 • Number of events 8 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
20.8%
36/173 • Number of events 45 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
16.4%
18/110 • Number of events 26 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
21.4%
25/117 • Number of events 33 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
26.7%
16/60 • Number of events 20 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Gastrointestinal disorders
Nausea
17.7%
11/62 • Number of events 12 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
23.8%
15/63 • Number of events 20 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
16.2%
28/173 • Number of events 33 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
20.0%
22/110 • Number of events 32 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
17.1%
20/117 • Number of events 25 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
18.3%
11/60 • Number of events 16 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Gastrointestinal disorders
Stomatitis
8.1%
5/62 • Number of events 6 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
7.9%
5/63 • Number of events 5 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
5.8%
10/173 • Number of events 11 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
4.5%
5/110 • Number of events 6 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
2.6%
3/117 • Number of events 3 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
1/60 • Number of events 3 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Gastrointestinal disorders
Vomiting
12.9%
8/62 • Number of events 8 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
6.3%
4/63 • Number of events 5 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
9.8%
17/173 • Number of events 17 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
7.3%
8/110 • Number of events 13 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
15.4%
18/117 • Number of events 22 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
11.7%
7/60 • Number of events 10 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
General disorders
Asthenia
9.7%
6/62 • Number of events 6 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
12.7%
8/63 • Number of events 17 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
17.9%
31/173 • Number of events 39 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
15.5%
17/110 • Number of events 19 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
13.7%
16/117 • Number of events 21 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
15.0%
9/60 • Number of events 9 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
General disorders
Fatigue
16.1%
10/62 • Number of events 10 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
15.9%
10/63 • Number of events 16 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
14.5%
25/173 • Number of events 27 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
21.8%
24/110 • Number of events 30 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
18.8%
22/117 • Number of events 24 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
6.7%
4/60 • Number of events 4 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
General disorders
Malaise
1.6%
1/62 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
6.3%
4/63 • Number of events 8 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
3/173 • Number of events 3 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
4.5%
5/110 • Number of events 5 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
6.8%
8/117 • Number of events 8 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
1/60 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
General disorders
Non-cardiac chest pain
6.5%
4/62 • Number of events 4 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
3.2%
2/63 • Number of events 3 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
2.3%
4/173 • Number of events 4 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
3.6%
4/110 • Number of events 4 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
2/117 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
1/60 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
General disorders
Oedema peripheral
9.7%
6/62 • Number of events 8 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
4.8%
3/63 • Number of events 5 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
9.2%
16/173 • Number of events 17 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
8.2%
9/110 • Number of events 10 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
6.8%
8/117 • Number of events 10 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
3.3%
2/60 • Number of events 3 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
General disorders
Pyrexia
14.5%
9/62 • Number of events 14 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
9.5%
6/63 • Number of events 8 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
11.6%
20/173 • Number of events 27 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
20.9%
23/110 • Number of events 33 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
10.3%
12/117 • Number of events 15 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
10.0%
6/60 • Number of events 7 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Infections and infestations
Influenza
3.2%
2/62 • Number of events 3 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/63 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
3/173 • Number of events 3 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/110 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
5.1%
6/117 • Number of events 6 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
1/60 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Infections and infestations
Viral upper respiratory tract infection
4.8%
3/62 • Number of events 5 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.6%
1/63 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
8.7%
15/173 • Number of events 18 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
4.5%
5/110 • Number of events 5 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
6.0%
7/117 • Number of events 8 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
1/60 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Investigations
Alanine aminotransferase increased
1.6%
1/62 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
4.8%
3/63 • Number of events 3 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
5.8%
10/173 • Number of events 11 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
9.1%
10/110 • Number of events 15 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
4.3%
5/117 • Number of events 9 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
8.3%
5/60 • Number of events 6 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Investigations
Aspartate aminotransferase increased
1.6%
1/62 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
3.2%
2/63 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
6.4%
11/173 • Number of events 12 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
7.3%
8/110 • Number of events 12 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
2/117 • Number of events 5 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
8.3%
5/60 • Number of events 6 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Investigations
Blood creatinine increased
3.2%
2/62 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
6.3%
4/63 • Number of events 4 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.2%
2/173 • Number of events 3 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
2.7%
3/110 • Number of events 6 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
3.4%
4/117 • Number of events 5 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
3.3%
2/60 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Investigations
Gamma-glutamyltransferase increased
6.5%
4/62 • Number of events 5 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
3.2%
2/63 • Number of events 3 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
2.3%
4/173 • Number of events 4 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.91%
1/110 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
1/60 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Investigations
Neutrophil count decreased
3.2%
2/62 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
14.3%
9/63 • Number of events 33 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.2%
2/173 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
16.4%
18/110 • Number of events 43 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Investigations
Platelet count decreased
1.6%
1/62 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
9.5%
6/63 • Number of events 8 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
7.3%
8/110 • Number of events 27 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Investigations
Weight decreased
9.7%
6/62 • Number of events 7 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
6.3%
4/63 • Number of events 4 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
8.1%
14/173 • Number of events 14 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
3.6%
4/110 • Number of events 4 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
6.8%
8/117 • Number of events 8 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
6.7%
4/60 • Number of events 4 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Investigations
White blood cell count decreased
1.6%
1/62 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
9.5%
6/63 • Number of events 21 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.2%
2/173 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
10.0%
11/110 • Number of events 32 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Metabolism and nutrition disorders
Decreased appetite
25.8%
16/62 • Number of events 19 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
31.7%
20/63 • Number of events 24 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
19.7%
34/173 • Number of events 39 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
20.9%
23/110 • Number of events 24 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
23.1%
27/117 • Number of events 28 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
20.0%
12/60 • Number of events 12 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Metabolism and nutrition disorders
Dehydration
1.6%
1/62 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.6%
1/63 • Number of events 3 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.58%
1/173 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.91%
1/110 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/117 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
6.7%
4/60 • Number of events 6 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Metabolism and nutrition disorders
Hyperkalaemia
8.1%
5/62 • Number of events 5 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.6%
1/63 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/173 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.91%
1/110 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
3.4%
4/117 • Number of events 5 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Metabolism and nutrition disorders
Hypokalaemia
8.1%
5/62 • Number of events 6 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
4.8%
3/63 • Number of events 3 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
3/173 • Number of events 3 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.8%
2/110 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
6.8%
8/117 • Number of events 10 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
15.0%
9/60 • Number of events 10 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Musculoskeletal and connective tissue disorders
Arthralgia
11.3%
7/62 • Number of events 8 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
4.8%
3/63 • Number of events 3 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
9.2%
16/173 • Number of events 19 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.8%
2/110 • Number of events 4 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
8.5%
10/117 • Number of events 10 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
6.7%
4/60 • Number of events 5 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Musculoskeletal and connective tissue disorders
Back pain
11.3%
7/62 • Number of events 7 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
9.5%
6/63 • Number of events 7 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
6.4%
11/173 • Number of events 13 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
3.6%
4/110 • Number of events 4 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
12.0%
14/117 • Number of events 15 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
6.7%
4/60 • Number of events 4 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
4.8%
3/62 • Number of events 5 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
3.2%
2/63 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
4.0%
7/173 • Number of events 7 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.8%
2/110 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
6.0%
7/117 • Number of events 7 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
3.3%
2/60 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
9.7%
6/62 • Number of events 8 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
6.3%
4/63 • Number of events 4 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
4.0%
7/173 • Number of events 10 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
4.5%
5/110 • Number of events 5 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
10.3%
12/117 • Number of events 12 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
1/60 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Musculoskeletal and connective tissue disorders
Myalgia
3.2%
2/62 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
4.8%
3/63 • Number of events 4 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
5.2%
9/173 • Number of events 9 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
3.6%
4/110 • Number of events 4 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
4.3%
5/117 • Number of events 5 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
1/60 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Musculoskeletal and connective tissue disorders
Pain in extremity
3.2%
2/62 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
3.2%
2/63 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
5.2%
9/173 • Number of events 11 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
4.5%
5/110 • Number of events 5 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
7.7%
9/117 • Number of events 11 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
10.0%
6/60 • Number of events 7 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
17.7%
11/62 • Number of events 12 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
14.3%
9/63 • Number of events 11 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
14.5%
25/173 • Number of events 26 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
13.6%
15/110 • Number of events 16 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
13.7%
16/117 • Number of events 17 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
10.0%
6/60 • Number of events 6 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Nervous system disorders
Dizziness
9.7%
6/62 • Number of events 6 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
7.9%
5/63 • Number of events 5 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
5.2%
9/173 • Number of events 10 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
4.5%
5/110 • Number of events 6 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
6.8%
8/117 • Number of events 8 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
5.0%
3/60 • Number of events 3 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Nervous system disorders
Headache
14.5%
9/62 • Number of events 11 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
11.1%
7/63 • Number of events 8 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
9.8%
17/173 • Number of events 19 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
5.5%
6/110 • Number of events 8 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
6.8%
8/117 • Number of events 8 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
8.3%
5/60 • Number of events 6 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Psychiatric disorders
Insomnia
11.3%
7/62 • Number of events 7 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
6.3%
4/63 • Number of events 4 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
3.5%
6/173 • Number of events 6 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
4.5%
5/110 • Number of events 5 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
6.0%
7/117 • Number of events 7 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
8.3%
5/60 • Number of events 5 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Respiratory, thoracic and mediastinal disorders
Cough
17.7%
11/62 • Number of events 13 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
7.9%
5/63 • Number of events 5 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
13.9%
24/173 • Number of events 29 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
12.7%
14/110 • Number of events 15 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
12.8%
15/117 • Number of events 20 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
8.3%
5/60 • Number of events 5 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
6.5%
4/62 • Number of events 8 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
3.2%
2/63 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
3.5%
6/173 • Number of events 7 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
3.6%
4/110 • Number of events 4 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
6.0%
7/117 • Number of events 7 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
1/60 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
9.7%
6/62 • Number of events 6 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.6%
1/63 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
2.3%
4/173 • Number of events 4 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.8%
2/110 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
1.7%
1/60 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Skin and subcutaneous tissue disorders
Dermatitis acneiform
4.8%
3/62 • Number of events 4 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
9.5%
6/63 • Number of events 6 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
3.5%
6/173 • Number of events 11 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
3.6%
4/110 • Number of events 4 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.85%
1/117 • Number of events 1 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
0.00%
0/60 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Skin and subcutaneous tissue disorders
Dry skin
0.00%
0/62 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
6.3%
4/63 • Number of events 4 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
2.3%
4/173 • Number of events 4 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
4.5%
5/110 • Number of events 5 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
3.4%
4/117 • Number of events 6 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
5.0%
3/60 • Number of events 3 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Skin and subcutaneous tissue disorders
Pruritus
11.3%
7/62 • Number of events 8 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
3.2%
2/63 • Number of events 2 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
16.2%
28/173 • Number of events 36 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
4.5%
5/110 • Number of events 5 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
9.4%
11/117 • Number of events 12 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
23.3%
14/60 • Number of events 17 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
Skin and subcutaneous tissue disorders
Rash
4.8%
3/62 • Number of events 4 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
14.3%
9/63 • Number of events 9 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
8.1%
14/173 • Number of events 15 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
15.5%
17/110 • Number of events 17 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
6.0%
7/117 • Number of events 9 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.
15.0%
9/60 • Number of events 11 • From signature of informed consent up to 90 days after the last dose of durvalumab and/or tremelimumab and 30 days after the last dose of SoC, approximately 15 months.
Sub-study A and B: Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality is defined as death due to any cause (including disease progression) for the entire duration of the study.

Additional Information

Medical Science Director

AstraZeneca

Phone: +1 302 885 1180

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place