Trial Outcomes & Findings for A Phase 1/2, Open-Label, Dose-Escalation, Safety Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors (NCT NCT02923349)
NCT ID: NCT02923349
Last Updated: 2025-08-24
Results Overview
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
87 participants
Primary outcome timeframe
From screening through 60 days after end of treatment, up to 11 months
Results posted on
2025-08-24
Participant Flow
The study was conducted at 4 different sites in US, 1 site in Switzerland,1 site in Spain and 2 sites in the United Kingdom.
A total of 129 participants were screened for this study, of which 42 participants were screen failures and 87 participants were randomized to treatment.
Participant milestones
| Measure |
PART 1 Dose 1 (7 mg)
INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 2 (20 mg)
INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 3 (70 mg)
INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 4 (200 mg)
INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 5 (350 mg)
INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 6 (700 mg)
INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 7 (1400 mg)
INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
22
|
18
|
23
|
12
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
5
|
2
|
4
|
5
|
1
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
17
|
16
|
19
|
7
|
3
|
Reasons for withdrawal
| Measure |
PART 1 Dose 1 (7 mg)
INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 2 (20 mg)
INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 3 (70 mg)
INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 4 (200 mg)
INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 5 (350 mg)
INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 6 (700 mg)
INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 7 (1400 mg)
INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Other
|
1
|
2
|
4
|
1
|
3
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
8
|
10
|
12
|
3
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
1
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
3
|
0
|
1
|
1
|
0
|
|
Overall Study
Death
|
1
|
0
|
2
|
4
|
2
|
3
|
0
|
Baseline Characteristics
A Phase 1/2, Open-Label, Dose-Escalation, Safety Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors
Baseline characteristics by cohort
| Measure |
PART 1 Dose 1 (7 mg)
n=4 Participants
INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 2 (20 mg)
n=4 Participants
INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 3 (70 mg)
n=22 Participants
INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 4 (200 mg)
n=18 Participants
INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 5 (350 mg)
n=23 Participants
INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 6 (700 mg)
n=12 Participants
INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 7 (1400 mg)
n=4 Participants
INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
54.3 years
STANDARD_DEVIATION 16.24 • n=5 Participants
|
63.8 years
STANDARD_DEVIATION 12.63 • n=7 Participants
|
56.8 years
STANDARD_DEVIATION 14.27 • n=5 Participants
|
58.9 years
STANDARD_DEVIATION 12.78 • n=4 Participants
|
58.1 years
STANDARD_DEVIATION 12.44 • n=21 Participants
|
61.3 years
STANDARD_DEVIATION 9.93 • n=10 Participants
|
52.8 years
STANDARD_DEVIATION 24.50 • n=115 Participants
|
58.2 years
STANDARD_DEVIATION 13.24 • n=6 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
53 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
34 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
19 participants
n=5 Participants
|
17 participants
n=4 Participants
|
23 participants
n=21 Participants
|
9 participants
n=10 Participants
|
4 participants
n=115 Participants
|
79 participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
0 participants
n=115 Participants
|
4 participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
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
|
2 participants
n=10 Participants
|
0 participants
n=115 Participants
|
2 participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
78 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
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=10 Participants
|
1 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: From screening through 60 days after end of treatment, up to 11 monthsPopulation: The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCAGN01949.
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
Outcome measures
| Measure |
PART 1 Dose 1 (7 mg)
n=4 Participants
INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 2 (20 mg)
n=4 Participants
INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 3 (70 mg)
n=22 Participants
INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 4 (200 mg)
n=18 Participants
INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 5 (350 mg)
n=23 Participants
INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 6 (700 mg)
n=12 Participants
INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 7 (1400 mg)
n=4 Participants
INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-related Adverse Events
|
4 Participants
|
4 Participants
|
21 Participants
|
17 Participants
|
22 Participants
|
11 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6Population: The PK evaluable population will include all subjects who received at least 1 dose of INCAGN01949 and provided at least 1 post dose sample (1 PK measurement).
To evaluate the Cmax of INCAGN01949 in subjects with advanced or metastatic solid tumors.
Outcome measures
| Measure |
PART 1 Dose 1 (7 mg)
n=4 Participants
INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 2 (20 mg)
n=4 Participants
INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 3 (70 mg)
n=21 Participants
INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 4 (200 mg)
n=17 Participants
INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 5 (350 mg)
n=21 Participants
INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 6 (700 mg)
n=7 Participants
INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 7 (1400 mg)
n=4 Participants
INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
|---|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of INCAGN01949 in Plasma
|
1630 ng/ml
Standard Deviation 735
|
5820 ng/ml
Standard Deviation 324
|
22300 ng/ml
Standard Deviation 32800
|
39200 ng/ml
Standard Deviation 10300
|
84900 ng/ml
Standard Deviation 76700
|
207000 ng/ml
Standard Deviation 45500
|
347000 ng/ml
Standard Deviation 130000
|
SECONDARY outcome
Timeframe: Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6Population: The PK evaluable population will include all subjects who received at least 1 dose of INCAGN01949 and provided at least 1 post dose sample (1 PK measurement).
To evaluate the AUC0-t of INCAGN01949 in subjects with advanced or metastatic solid tumors
Outcome measures
| Measure |
PART 1 Dose 1 (7 mg)
n=4 Participants
INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 2 (20 mg)
n=4 Participants
INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 3 (70 mg)
n=21 Participants
INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 4 (200 mg)
n=17 Participants
INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 5 (350 mg)
n=21 Participants
INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 6 (700 mg)
n=7 Participants
INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 7 (1400 mg)
n=4 Participants
INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
|---|---|---|---|---|---|---|---|
|
Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949
cycle 1
|
185 ug*hr/mL
Standard Deviation 81.7
|
904 ug*hr/mL
Standard Deviation 197
|
2370 ug*hr/mL
Standard Deviation 841
|
5400 ug*hr/mL
Standard Deviation 1820
|
10000 ug*hr/mL
Standard Deviation 5600
|
28300 ug*hr/mL
Standard Deviation 7720
|
61600 ug*hr/mL
Standard Deviation 9130
|
|
Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949
cycle 6
|
427 ug*hr/mL
Standard Deviation 9.21
|
—
|
5490 ug*hr/mL
Standard Deviation 1560
|
10700 ug*hr/mL
Standard Deviation 6560
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and every 8 weeks,up to 11 monthsPopulation: The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCAGN01949.
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
Outcome measures
| Measure |
PART 1 Dose 1 (7 mg)
n=4 Participants
INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 2 (20 mg)
n=4 Participants
INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 3 (70 mg)
n=22 Participants
INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 4 (200 mg)
n=18 Participants
INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 5 (350 mg)
n=23 Participants
INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 6 (700 mg)
n=12 Participants
INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 7 (1400 mg)
n=4 Participants
INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
|---|---|---|---|---|---|---|---|
|
Objective Response Rate Per RECIST and Modified RECIST
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and every 8 weeks, up to 11 monthsPopulation: The Full Analysis Set population included all subjects enrolled in the study who received at least 1 dose of INCAGN01949. Median was not estimable due to insufficient number of participants with response
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
Outcome measures
| Measure |
PART 1 Dose 1 (7 mg)
INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 2 (20 mg)
INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 3 (70 mg)
INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 4 (200 mg)
INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 5 (350 mg)
INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 6 (700 mg)
n=1 Participants
INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 7 (1400 mg)
INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
|---|---|---|---|---|---|---|---|
|
Duration of Response Per RECIST and Modified RECIST
|
—
|
—
|
—
|
—
|
—
|
192 days
Full Range 192 • Interval 192.0 to 192.0
|
—
|
SECONDARY outcome
Timeframe: Baseline and every 8 weeks, up to 11 monthsPopulation: The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCAGN01949.
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
Outcome measures
| Measure |
PART 1 Dose 1 (7 mg)
n=4 Participants
INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 2 (20 mg)
n=4 Participants
INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 3 (70 mg)
n=22 Participants
INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 4 (200 mg)
n=18 Participants
INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 5 (350 mg)
n=23 Participants
INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 6 (700 mg)
n=12 Participants
INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 7 (1400 mg)
n=4 Participants
INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
|---|---|---|---|---|---|---|---|
|
Progression-free Survival Per RECIST and Modified RECIST
|
57 Days
Full Range 55 • Interval 55.0 to 59.0
|
47.5 Days
Full Range 29 • Interval 29.0 to 112.0
|
54.0 Days
Full Range 23 • Interval 23.0 to 216.0
|
56.0 Days
Full Range 26 • Interval 26.0 to 281.0
|
52.0 Days
Full Range 1 • Interval 1.0 to 166.0
|
125.0 Days
Full Range 21 • Interval 21.0 to 298.0
|
46.5 Days
Full Range 42 • Interval 42.0 to 53.0
|
SECONDARY outcome
Timeframe: Baseline and every 8 weeks, up to 11 monthsPopulation: The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCAGN01949. Median was not estimable due to insufficient number of participants with CR, PR, and SD
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
Outcome measures
| Measure |
PART 1 Dose 1 (7 mg)
n=1 Participants
INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 2 (20 mg)
n=1 Participants
INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 3 (70 mg)
n=8 Participants
INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 4 (200 mg)
n=7 Participants
INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 5 (350 mg)
n=3 Participants
INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 6 (700 mg)
n=7 Participants
INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 7 (1400 mg)
INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
|---|---|---|---|---|---|---|---|
|
Duration of Disease Control Per RECIST and Modified RECIST
|
0 Days
Interval 0.0 to 0.0
|
57 Days
Interval 57.0 to 57.0
|
64 Days
Interval 1.0 to 160.0
|
57 Days
Interval 1.0 to 225.0
|
NA Days
Interval 1.0 to 112.0
The numbers reported were censored durations of stable disease for the participants. Median is not estimable as Kaplan-Meier method requires at least 1 event to determine where the curve hits 50% rate of estimated durations
|
120 Days
Interval 1.0 to 249.0
|
—
|
SECONDARY outcome
Timeframe: Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6Population: The PK evaluable population will include all subjects who received at least 1 dose of INCAGN01949 and provided at least 1 post dose sample (1 PK measurement).
To evaluate the Tmax of INCAGN01949 in subjects with advanced or metastatic solid tumors.
Outcome measures
| Measure |
PART 1 Dose 1 (7 mg)
n=4 Participants
INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 2 (20 mg)
n=4 Participants
INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 3 (70 mg)
n=21 Participants
INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 4 (200 mg)
n=17 Participants
INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 5 (350 mg)
n=21 Participants
INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 6 (700 mg)
n=7 Participants
INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 7 (1400 mg)
n=4 Participants
INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
|---|---|---|---|---|---|---|---|
|
Time to Maximum Concentration of INCAGN01949 in Plasma
cycle 1
|
0.64 hr
Interval 0.6 to 4.4
|
2.53 hr
Interval 0.55 to 4.5
|
4.3 hr
Interval 0.5 to 25.2
|
0.63 hr
Interval 0.5 to 4.5
|
0.6 hr
Interval 0.0 to 194.0
|
0.7 hr
Interval 0.53 to 4.2
|
0.73 hr
Interval 0.0 to 2.43
|
|
Time to Maximum Concentration of INCAGN01949 in Plasma
cycle 6
|
0.78 hr
Interval 0.75 to 0.8
|
—
|
0.63 hr
Interval 0.5 to 4.3
|
0.61 hr
Interval 0.55 to 4.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6Population: The PK evaluable population will include all subjects who received at least 1 dose of INCAGN01949 and provided at least 1 post dose sample (1 PK measurement).
To evaluate the Cmin of INCAGN01949 in subjects with advanced or metastatic solid tumors. Cmin is the minimum observed concentration of INCAGN1949
Outcome measures
| Measure |
PART 1 Dose 1 (7 mg)
n=4 Participants
INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 2 (20 mg)
n=4 Participants
INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 3 (70 mg)
n=22 Participants
INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 4 (200 mg)
n=18 Participants
INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 5 (350 mg)
n=23 Participants
INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 6 (700 mg)
n=12 Participants
INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 7 (1400 mg)
n=4 Participants
INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
|---|---|---|---|---|---|---|---|
|
Summary of Trough Concentrations(Cmin) of INCAGN01949
cycle 2
|
303 ng/mL
Standard Deviation 202
|
1890 ng/mL
Standard Deviation 1570
|
3620 ng/mL
Standard Deviation 1550
|
8880 ng/mL
Standard Deviation 4510
|
17000 ng/mL
Standard Deviation 8040
|
41000 ng/mL
Standard Deviation 13000
|
117000 ng/mL
Standard Deviation 19300
|
|
Summary of Trough Concentrations(Cmin) of INCAGN01949
cycle 3
|
753 ng/mL
Standard Deviation 163
|
1520 ng/mL
Standard Deviation 225
|
5620 ng/mL
Standard Deviation 3280
|
14300 ng/mL
Standard Deviation 7740
|
29400 ng/mL
Standard Deviation 18400
|
77800 ng/mL
Standard Deviation 27900
|
163000 ng/mL
Standard Deviation 32900
|
|
Summary of Trough Concentrations(Cmin) of INCAGN01949
cycle 4
|
895 ng/mL
Standard Deviation 80.2
|
1780 ng/mL
Standard Deviation 318
|
5110 ng/mL
Standard Deviation 2850
|
17900 ng/mL
Standard Deviation 13200
|
42200 ng/mL
Standard Deviation 28500
|
84600 ng/mL
Standard Deviation 17700
|
282000 ng/mL
Standard Deviation 165000
|
|
Summary of Trough Concentrations(Cmin) of INCAGN01949
cycle 6
|
785 ng/mL
Standard Deviation 39.6
|
—
|
9150 ng/mL
Standard Deviation 2420
|
19600 ng/mL
Standard Deviation 13100
|
43400 ng/mL
Standard Deviation 26500
|
—
|
—
|
|
Summary of Trough Concentrations(Cmin) of INCAGN01949
cycle 7
|
—
|
—
|
10200 ng/mL
Standard Deviation 2190
|
21600 ng/mL
Standard Deviation 10600
|
—
|
—
|
—
|
Adverse Events
PART 1 Dose 1 (7 mg)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
PART 1 Dose 2 (20 mg)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
PART 1 Dose 3 (70 mg)
Serious events: 8 serious events
Other events: 21 other events
Deaths: 2 deaths
PART 1 Dose 4 (200 mg)
Serious events: 9 serious events
Other events: 17 other events
Deaths: 4 deaths
PART 1 Dose 5 (350 mg)
Serious events: 9 serious events
Other events: 22 other events
Deaths: 2 deaths
PART 1 Dose 6 (700 mg)
Serious events: 5 serious events
Other events: 10 other events
Deaths: 3 deaths
PART 1 Dose 7 (1400 mg)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PART 1 Dose 1 (7 mg)
n=4 participants at risk
INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 2 (20 mg)
n=4 participants at risk
INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 3 (70 mg)
n=22 participants at risk
INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 4 (200 mg)
n=18 participants at risk
INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 5 (350 mg)
n=23 participants at risk
INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 6 (700 mg)
n=12 participants at risk
INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 7 (1400 mg)
n=4 participants at risk
INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
4.5%
1/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
4.3%
1/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
4.5%
1/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
4.3%
1/23 • From screening through 60 days after end of treatment, up to 11 months
|
16.7%
2/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
4.3%
1/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Infections and infestations
Appendicitis
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
4.3%
1/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
4.3%
1/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Nervous system disorders
Ataxia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
4.3%
1/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
4.5%
1/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
4.3%
1/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
4.5%
1/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Nervous system disorders
Cauda equina syndrome
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
4.3%
1/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
4.5%
1/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
4.3%
1/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
4.3%
1/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Vascular disorders
Embolism
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
4.3%
1/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
General disorders
General physical health deterioration
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
4.5%
1/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
4.3%
1/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
4.5%
1/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
8.7%
2/23 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
3/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Infections and infestations
Myelitis
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
4.3%
1/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
4.5%
1/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
General disorders
Oedema
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
4.5%
1/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
General disorders
Pain
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
General disorders
Pyrexia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
4.3%
1/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
11.1%
2/18 • From screening through 60 days after end of treatment, up to 11 months
|
8.7%
2/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
4.5%
1/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
4.3%
1/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
4.5%
1/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
4.3%
1/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
Other adverse events
| Measure |
PART 1 Dose 1 (7 mg)
n=4 participants at risk
INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 2 (20 mg)
n=4 participants at risk
INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 3 (70 mg)
n=22 participants at risk
INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 4 (200 mg)
n=18 participants at risk
INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 5 (350 mg)
n=23 participants at risk
INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 6 (700 mg)
n=12 participants at risk
INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
PART 1 Dose 7 (1400 mg)
n=4 participants at risk
INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
|
|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Tumour pruritus
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
4.5%
1/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
4.5%
1/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
4.3%
1/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
11.1%
2/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
22.7%
5/22 • From screening through 60 days after end of treatment, up to 11 months
|
16.7%
3/18 • From screening through 60 days after end of treatment, up to 11 months
|
17.4%
4/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Investigations
Weight decreased
|
50.0%
2/4 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
11.1%
2/18 • From screening through 60 days after end of treatment, up to 11 months
|
8.7%
2/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Investigations
Weight increased
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Infections and infestations
Wound infection
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
4.5%
1/22 • From screening through 60 days after end of treatment, up to 11 months
|
16.7%
3/18 • From screening through 60 days after end of treatment, up to 11 months
|
17.4%
4/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Investigations
Amylase increased
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
11.1%
2/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
18.2%
4/22 • From screening through 60 days after end of treatment, up to 11 months
|
11.1%
2/18 • From screening through 60 days after end of treatment, up to 11 months
|
4.3%
1/23 • From screening through 60 days after end of treatment, up to 11 months
|
16.7%
2/12 • From screening through 60 days after end of treatment, up to 11 months
|
50.0%
2/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
75.0%
3/4 • From screening through 60 days after end of treatment, up to 11 months
|
13.6%
3/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
4.3%
1/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
4.3%
1/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
4.3%
1/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
General disorders
Asthenia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
9.1%
2/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Nervous system disorders
Ataxia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
13.6%
3/22 • From screening through 60 days after end of treatment, up to 11 months
|
11.1%
2/18 • From screening through 60 days after end of treatment, up to 11 months
|
21.7%
5/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Investigations
Blood alkaline phosphatase increased
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
16.7%
2/12 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Investigations
Blood bilirubin increased
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
16.7%
2/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Investigations
Blood creatinine increased
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
8.7%
2/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Investigations
Blood urea increased
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
4.5%
1/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Investigations
C-reactive protein increased
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
General disorders
Chills
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
4.5%
1/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
8.7%
2/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
18.2%
4/22 • From screening through 60 days after end of treatment, up to 11 months
|
33.3%
6/18 • From screening through 60 days after end of treatment, up to 11 months
|
17.4%
4/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
18.2%
4/22 • From screening through 60 days after end of treatment, up to 11 months
|
27.8%
5/18 • From screening through 60 days after end of treatment, up to 11 months
|
4.3%
1/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
75.0%
3/4 • From screening through 60 days after end of treatment, up to 11 months
|
27.3%
6/22 • From screening through 60 days after end of treatment, up to 11 months
|
22.2%
4/18 • From screening through 60 days after end of treatment, up to 11 months
|
30.4%
7/23 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
3/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
4.5%
1/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
4.5%
1/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
4.3%
1/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
13.6%
3/22 • From screening through 60 days after end of treatment, up to 11 months
|
22.2%
4/18 • From screening through 60 days after end of treatment, up to 11 months
|
13.0%
3/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
4.5%
1/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
4.3%
1/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Nervous system disorders
Dysgeusia
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
4.5%
1/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
50.0%
2/4 • From screening through 60 days after end of treatment, up to 11 months
|
9.1%
2/22 • From screening through 60 days after end of treatment, up to 11 months
|
16.7%
3/18 • From screening through 60 days after end of treatment, up to 11 months
|
13.0%
3/23 • From screening through 60 days after end of treatment, up to 11 months
|
16.7%
2/12 • From screening through 60 days after end of treatment, up to 11 months
|
50.0%
2/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
4.5%
1/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
16.7%
2/12 • From screening through 60 days after end of treatment, up to 11 months
|
50.0%
2/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
General disorders
Early satiety
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
4.5%
1/22 • Number of events 1 • From screening through 60 days after end of treatment, up to 11 months
|
11.1%
2/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
4.5%
1/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
4.5%
1/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
4.3%
1/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
General disorders
Fatigue
|
50.0%
2/4 • From screening through 60 days after end of treatment, up to 11 months
|
50.0%
2/4 • From screening through 60 days after end of treatment, up to 11 months
|
27.3%
6/22 • From screening through 60 days after end of treatment, up to 11 months
|
38.9%
7/18 • From screening through 60 days after end of treatment, up to 11 months
|
34.8%
8/23 • From screening through 60 days after end of treatment, up to 11 months
|
33.3%
4/12 • From screening through 60 days after end of treatment, up to 11 months
|
50.0%
2/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
9.1%
2/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
4.5%
1/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
4.3%
1/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
4.5%
1/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
9.1%
2/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
4.3%
1/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
4.3%
1/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
11.1%
2/18 • From screening through 60 days after end of treatment, up to 11 months
|
4.3%
1/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
4.5%
1/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Investigations
Lipase increased
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
4.3%
1/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Investigations
Lymph node palpable
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
9.1%
2/22 • Number of events 2 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
4.3%
1/23 • Number of events 1 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • Number of events 1 • From screening through 60 days after end of treatment, up to 11 months
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
4.5%
1/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
50.0%
2/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
4.3%
1/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
13.6%
3/22 • Number of events 5 • From screening through 60 days after end of treatment, up to 11 months
|
16.7%
3/18 • From screening through 60 days after end of treatment, up to 11 months
|
26.1%
6/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
4.5%
1/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
9.1%
2/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
General disorders
Nodule
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
4.5%
1/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
4.5%
1/22 • From screening through 60 days after end of treatment, up to 11 months
|
16.7%
3/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
16.7%
2/12 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Infections and infestations
Oral herpes
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
4.5%
1/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
General disorders
Peripheral swelling
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
9.1%
2/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
8.7%
2/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
4.5%
1/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
9.1%
2/22 • From screening through 60 days after end of treatment, up to 11 months
|
11.1%
2/18 • From screening through 60 days after end of treatment, up to 11 months
|
8.7%
2/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
General disorders
Pyrexia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
50.0%
2/4 • From screening through 60 days after end of treatment, up to 11 months
|
4.5%
1/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
8.7%
2/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
9.1%
2/22 • From screening through 60 days after end of treatment, up to 11 months
|
11.1%
2/18 • From screening through 60 days after end of treatment, up to 11 months
|
4.3%
1/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
11.1%
2/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Infections and infestations
Rash pustular
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
8.7%
2/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
9.1%
2/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Nervous system disorders
Spinal cord compression
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
25.0%
1/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
8.3%
1/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/22 • From screening through 60 days after end of treatment, up to 11 months
|
5.6%
1/18 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/23 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/12 • From screening through 60 days after end of treatment, up to 11 months
|
0.00%
0/4 • From screening through 60 days after end of treatment, up to 11 months
|
Additional Information
Incyte Biosciences International Sàrl
Incyte Corporation Call Centre
Phone: 8554633463
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Clinical Study Agreement
- Publication restrictions are in place
Restriction type: OTHER