Trial Outcomes & Findings for Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer (ARTISTRY-7) (NCT NCT05092360)
NCT ID: NCT05092360
Last Updated: 2025-08-28
Results Overview
Estimates based on Kaplan-Meier method.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
456 participants
Primary outcome timeframe
From the first dose of study drug up to 24 months
Results posted on
2025-08-28
Participant Flow
The study was conducted globally from 10 Jan 2022 to 08 May 2025.
Participants with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer were enrolled into 1 of 4 arms to receive nemvaleukin alfa (ALKS 4230) either as monotherapy or in combination with pembrolizumab or in investigator's choice chemotherapy. Study was terminated due to business and strategic decision.
Participant milestones
| Measure |
Nemvaleukin 6 mcg/kg and Pembrolizumab 200 mg
Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles and Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
|
Pembrolizumab 200 mg
Participants received Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
|
Nemvaleukin 6 mcg/kg
Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles.
|
Investigator's Choice Chemotherapy
Investigator's choice chemotherapy includes one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator pre-selected the Investigator's choice treatment before the randomization of each participant.
Pegylated Liposomal Doxorubicin (PLD): 40 mg/m\^2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+).
Paclitaxel: 80 mg/m\^2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min.
Topotecan: 4 mg/m\^2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min.
Gemcitabine: 1,000 mg/m\^2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
184
|
27
|
55
|
190
|
|
Overall Study
Intent to Treat Population
|
184
|
27
|
55
|
190
|
|
Overall Study
Safety Set Population
|
178
|
26
|
53
|
175
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
184
|
27
|
55
|
190
|
Reasons for withdrawal
| Measure |
Nemvaleukin 6 mcg/kg and Pembrolizumab 200 mg
Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles and Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
|
Pembrolizumab 200 mg
Participants received Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
|
Nemvaleukin 6 mcg/kg
Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles.
|
Investigator's Choice Chemotherapy
Investigator's choice chemotherapy includes one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator pre-selected the Investigator's choice treatment before the randomization of each participant.
Pegylated Liposomal Doxorubicin (PLD): 40 mg/m\^2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+).
Paclitaxel: 80 mg/m\^2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min.
Topotecan: 4 mg/m\^2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min.
Gemcitabine: 1,000 mg/m\^2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
21
|
4
|
9
|
26
|
|
Overall Study
Death
|
97
|
14
|
31
|
101
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
2
|
2
|
|
Overall Study
Study terminated by sponsor
|
65
|
7
|
13
|
61
|
Baseline Characteristics
Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer (ARTISTRY-7)
Baseline characteristics by cohort
| Measure |
Nemvaleukin 6 mcg/kg and Pembrolizumab 200 mg
n=184 Participants
Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles and Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
|
Pembrolizumab 200 mg
n=27 Participants
Participants received Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
|
Nemvaleukin 6 mcg/kg
n=55 Participants
Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles.
|
Investigator's Choice Chemotherapy
n=190 Participants
Investigator's choice chemotherapy includes one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator pre-selected the Investigator's choice treatment before the randomization of each participant.
Pegylated Liposomal Doxorubicin (PLD): 40 mg/m\^2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+).
Paclitaxel: 80 mg/m\^2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min.
Topotecan: 4 mg/m\^2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min.
Gemcitabine: 1,000 mg/m\^2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min.
|
Total
n=456 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 8.83 • n=99 Participants
|
61.6 years
STANDARD_DEVIATION 12.97 • n=107 Participants
|
61.5 years
STANDARD_DEVIATION 9.17 • n=206 Participants
|
61.3 years
STANDARD_DEVIATION 9.99 • n=7 Participants
|
61.8 years
STANDARD_DEVIATION 9.63 • n=31 Participants
|
|
Sex: Female, Male
Female
|
184 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
190 Participants
n=7 Participants
|
456 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
165 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
175 Participants
n=7 Participants
|
419 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
42 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
33 Participants
n=7 Participants
|
83 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
113 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
142 Participants
n=7 Participants
|
326 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
24 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
39 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to 24 monthsPopulation: ITT population.
Estimates based on Kaplan-Meier method.
Outcome measures
| Measure |
Nemvaleukin 6 mcg/kg and Pembrolizumab 200 mg
n=184 Participants
Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles and Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
|
Pembrolizumab 200 mg
n=27 Participants
Participants received Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
|
Nemvaleukin 6 mcg/kg
n=55 Participants
Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles.
|
Investigator's Choice Chemotherapy
n=190 Participants
Investigator's choice chemotherapy includes one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator pre-selected the Investigator's choice treatment before the randomization of each participant.
Pegylated Liposomal Doxorubicin (PLD): 40 mg/m\^2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+).
Paclitaxel: 80 mg/m\^2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min.
Topotecan: 4 mg/m\^2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min.
Gemcitabine: 1,000 mg/m\^2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min.
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
10.1 months
Interval 7.4 to 12.5
|
10.1 months
Interval 4.0 to
Higher limit of 95% CI could not be assessed due to the limited number of participants and death events within this reporting group.
|
10.7 months
Interval 8.1 to 13.9
|
9.8 months
Interval 8.2 to 11.5
|
SECONDARY outcome
Timeframe: From the first dose of study drug up to 20 monthsPopulation: ITT population.
Response is based on RECIST v1.1 criteria.
Outcome measures
| Measure |
Nemvaleukin 6 mcg/kg and Pembrolizumab 200 mg
n=184 Participants
Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles and Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
|
Pembrolizumab 200 mg
n=27 Participants
Participants received Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
|
Nemvaleukin 6 mcg/kg
n=55 Participants
Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles.
|
Investigator's Choice Chemotherapy
n=190 Participants
Investigator's choice chemotherapy includes one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator pre-selected the Investigator's choice treatment before the randomization of each participant.
Pegylated Liposomal Doxorubicin (PLD): 40 mg/m\^2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+).
Paclitaxel: 80 mg/m\^2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min.
Topotecan: 4 mg/m\^2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min.
Gemcitabine: 1,000 mg/m\^2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min.
|
|---|---|---|---|---|
|
Objective Response Rate (ORR) as Assessed by Investigator
|
9.2 percentage of participants
Interval 5.5 to 14.4
|
0.0 percentage of participants
Interval 0.0 to 6.5
|
0.0 percentage of participants
Interval 0.0 to 12.8
|
11.1 percentage of participants
Interval 7.0 to 16.4
|
SECONDARY outcome
Timeframe: From the first dose of study drug up to 20 monthsPopulation: ITT population.
Response is based on RECIST v1.1 criteria.
Outcome measures
| Measure |
Nemvaleukin 6 mcg/kg and Pembrolizumab 200 mg
n=184 Participants
Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles and Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
|
Pembrolizumab 200 mg
n=27 Participants
Participants received Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
|
Nemvaleukin 6 mcg/kg
n=55 Participants
Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles.
|
Investigator's Choice Chemotherapy
n=190 Participants
Investigator's choice chemotherapy includes one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator pre-selected the Investigator's choice treatment before the randomization of each participant.
Pegylated Liposomal Doxorubicin (PLD): 40 mg/m\^2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+).
Paclitaxel: 80 mg/m\^2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min.
Topotecan: 4 mg/m\^2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min.
Gemcitabine: 1,000 mg/m\^2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min.
|
|---|---|---|---|---|
|
Disease Control Rate (DCR) as Assessed by Investigator
|
34.2 percentage of participants
Interval 27.4 to 41.6
|
25.9 percentage of participants
Interval 11.1 to 46.3
|
36.4 percentage of participants
Interval 23.8 to 50.4
|
52.1 percentage of participants
Interval 44.8 to 59.4
|
SECONDARY outcome
Timeframe: From the first dose of study drug up to 20 monthsPopulation: ITT population. Here N refers to number of participants with response and were analyzed for this outcome measure.
Response is based on RECIST v1.1 criteria.
Outcome measures
| Measure |
Nemvaleukin 6 mcg/kg and Pembrolizumab 200 mg
n=17 Participants
Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles and Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
|
Pembrolizumab 200 mg
Participants received Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
|
Nemvaleukin 6 mcg/kg
Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles.
|
Investigator's Choice Chemotherapy
n=21 Participants
Investigator's choice chemotherapy includes one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator pre-selected the Investigator's choice treatment before the randomization of each participant.
Pegylated Liposomal Doxorubicin (PLD): 40 mg/m\^2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+).
Paclitaxel: 80 mg/m\^2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min.
Topotecan: 4 mg/m\^2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min.
Gemcitabine: 1,000 mg/m\^2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min.
|
|---|---|---|---|---|
|
Duration of Response (DOR) as Assessed by Investigator
|
5.9 months
Interval 2.1 to 14.7
|
—
|
—
|
5.4 months
Interval 1.4 to 12.6
|
SECONDARY outcome
Timeframe: From the first dose of study drug up to 20 monthsPopulation: ITT population. Here N refers to number of participants with response and were analyzed for this outcome measure.
Response is based on RECIST v1.1 criteria.
Outcome measures
| Measure |
Nemvaleukin 6 mcg/kg and Pembrolizumab 200 mg
n=17 Participants
Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles and Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
|
Pembrolizumab 200 mg
Participants received Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
|
Nemvaleukin 6 mcg/kg
Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles.
|
Investigator's Choice Chemotherapy
n=21 Participants
Investigator's choice chemotherapy includes one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator pre-selected the Investigator's choice treatment before the randomization of each participant.
Pegylated Liposomal Doxorubicin (PLD): 40 mg/m\^2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+).
Paclitaxel: 80 mg/m\^2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min.
Topotecan: 4 mg/m\^2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min.
Gemcitabine: 1,000 mg/m\^2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min.
|
|---|---|---|---|---|
|
Time to Response (TTR) as Assessed by Investigator
|
2.83 months
Interval 1.4 to 5.7
|
—
|
—
|
1.64 months
Interval 1.3 to 10.9
|
SECONDARY outcome
Timeframe: From the first dose of study drug up to 20 monthsPopulation: ITT population.
A Cancer Antigen-125 response is defined as at least a 50% reduction in CA-125 levels from baseline, and the response must be confirmed and maintained for at least 28 days as per the GCIG.
Outcome measures
| Measure |
Nemvaleukin 6 mcg/kg and Pembrolizumab 200 mg
n=184 Participants
Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles and Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
|
Pembrolizumab 200 mg
n=27 Participants
Participants received Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
|
Nemvaleukin 6 mcg/kg
n=55 Participants
Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles.
|
Investigator's Choice Chemotherapy
n=190 Participants
Investigator's choice chemotherapy includes one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator pre-selected the Investigator's choice treatment before the randomization of each participant.
Pegylated Liposomal Doxorubicin (PLD): 40 mg/m\^2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+).
Paclitaxel: 80 mg/m\^2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min.
Topotecan: 4 mg/m\^2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min.
Gemcitabine: 1,000 mg/m\^2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min.
|
|---|---|---|---|---|
|
Percentage of Participants With Cancer Antigen (CA)-125 Response as Defined by the Gynecologic Cancer Inter Group (GCIG)
|
4.3 percentage of participants
Interval 1.9 to 8.4
|
0.0 percentage of participants
Interval 0.0 to 12.8
|
0.0 percentage of participants
Interval 0.0 to 6.5
|
13.2 percentage of participants
Interval 8.7 to 18.8
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 90 days after last dose (up to 23 months)Population: Safety Set population.
Outcome measures
| Measure |
Nemvaleukin 6 mcg/kg and Pembrolizumab 200 mg
n=178 Participants
Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles and Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
|
Pembrolizumab 200 mg
n=26 Participants
Participants received Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
|
Nemvaleukin 6 mcg/kg
n=53 Participants
Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles.
|
Investigator's Choice Chemotherapy
n=175 Participants
Investigator's choice chemotherapy includes one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator pre-selected the Investigator's choice treatment before the randomization of each participant.
Pegylated Liposomal Doxorubicin (PLD): 40 mg/m\^2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+).
Paclitaxel: 80 mg/m\^2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min.
Topotecan: 4 mg/m\^2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min.
Gemcitabine: 1,000 mg/m\^2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
177 Participants
|
23 Participants
|
51 Participants
|
171 Participants
|
SECONDARY outcome
Timeframe: From the first dose of study drug up to 20 monthsPopulation: ITT population.
Outcome measures
| Measure |
Nemvaleukin 6 mcg/kg and Pembrolizumab 200 mg
n=184 Participants
Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles and Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
|
Pembrolizumab 200 mg
n=27 Participants
Participants received Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
|
Nemvaleukin 6 mcg/kg
n=55 Participants
Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles.
|
Investigator's Choice Chemotherapy
n=190 Participants
Investigator's choice chemotherapy includes one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator pre-selected the Investigator's choice treatment before the randomization of each participant.
Pegylated Liposomal Doxorubicin (PLD): 40 mg/m\^2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+).
Paclitaxel: 80 mg/m\^2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min.
Topotecan: 4 mg/m\^2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min.
Gemcitabine: 1,000 mg/m\^2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min.
|
|---|---|---|---|---|
|
Progression-free Survival (PFS) as Assessed by Investigator
|
1.5 months
Interval 1.4 to 1.7
|
1.5 months
Interval 1.4 to 2.4
|
1.5 months
Interval 1.3 to 2.6
|
2.9 months
Interval 2.6 to 4.0
|
Adverse Events
Nemvaleukin 6 mcg/kg and Pembrolizumab 200 mg
Serious events: 74 serious events
Other events: 177 other events
Deaths: 104 deaths
Pembrolizumab 200 mg
Serious events: 8 serious events
Other events: 23 other events
Deaths: 15 deaths
Nemvaleukin 6 mcg/kg
Serious events: 17 serious events
Other events: 51 other events
Deaths: 34 deaths
Investigator's Choice Chemotherapy
Serious events: 51 serious events
Other events: 171 other events
Deaths: 105 deaths
Serious adverse events
| Measure |
Nemvaleukin 6 mcg/kg and Pembrolizumab 200 mg
n=184 participants at risk
Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles and Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
|
Pembrolizumab 200 mg
n=27 participants at risk
Participants received Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
|
Nemvaleukin 6 mcg/kg
n=55 participants at risk
Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles.
|
Investigator's Choice Chemotherapy
n=190 participants at risk
Investigator's choice chemotherapy includes one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator pre-selected the Investigator's choice treatment before the randomization of each participant.
Pegylated Liposomal Doxorubicin (PLD): 40 mg/m\^2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+).
Paclitaxel: 80 mg/m\^2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min.
Topotecan: 4 mg/m\^2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min.
Gemcitabine: 1,000 mg/m\^2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.1%
2/190 • Number of events 2 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Cardiac disorders
Cardiac failure
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Cardiac disorders
Cardiac tamponade
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Cardiac disorders
Myocarditis
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Cardiac disorders
Pericarditis
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Ear and labyrinth disorders
Vertigo
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
4/184 • Number of events 4 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.6%
3/190 • Number of events 3 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Gastrointestinal disorders
Ascites
|
2.7%
5/184 • Number of events 5 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
1/27 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Gastrointestinal disorders
Colitis
|
1.1%
2/184 • Number of events 2 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
1/27 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Gastrointestinal disorders
Ileus
|
1.6%
3/184 • Number of events 3 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
3.3%
6/184 • Number of events 6 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
2.1%
4/190 • Number of events 4 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Gastrointestinal disorders
Intestinal pseudo-obstruction
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Gastrointestinal disorders
Intestinal stenosis
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Gastrointestinal disorders
Malignant gastrointestinal obstruction
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Gastrointestinal disorders
Melaena
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Gastrointestinal disorders
Nausea
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.1%
2/190 • Number of events 2 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Gastrointestinal disorders
Rectal perforation
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.6%
3/184 • Number of events 3 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
1/27 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Gastrointestinal disorders
Stomatitis
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
1/27 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
6/184 • Number of events 6 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.6%
3/190 • Number of events 3 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
General disorders
Chest discomfort
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
General disorders
Fatigue
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
General disorders
General physical health deterioration
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.6%
2/55 • Number of events 2 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
General disorders
Localised oedema
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
General disorders
Malaise
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
General disorders
Non-cardiac chest pain
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
General disorders
Oedema peripheral
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
General disorders
Pain
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
General disorders
Pyrexia
|
2.2%
4/184 • Number of events 4 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Hepatobiliary disorders
Hepatitis
|
1.1%
2/184 • Number of events 2 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
1/27 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Immune system disorders
Cytokine release syndrome
|
3.8%
7/184 • Number of events 7 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Immune system disorders
Bacteraemia
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Immune system disorders
Biliary tract infection
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Immune system disorders
COVID-19
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Immune system disorders
Catheter site infection
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Immune system disorders
Cellulitis
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Immune system disorders
Diverticulitis
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Immune system disorders
Empyema
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Immune system disorders
Enterobacter sepsis
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Immune system disorders
Erysipeloid
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Immune system disorders
Infection
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Immune system disorders
Influenza
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Immune system disorders
Pneumonia
|
1.1%
2/184 • Number of events 2 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Immune system disorders
Pulmonary sepsis
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Immune system disorders
Pyelonephritis
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Immune system disorders
Salmonella sepsis
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Immune system disorders
Sepsis
|
1.1%
2/184 • Number of events 2 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
1/27 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.6%
3/190 • Number of events 3 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Immune system disorders
Septic shock
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Immune system disorders
Urinary tract infection
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.1%
2/190 • Number of events 2 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Immune system disorders
Wound infection bacterial
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.1%
2/184 • Number of events 2 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
1/27 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Investigations
Aspartate aminotransferase increased
|
1.1%
2/184 • Number of events 2 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Investigations
Blood bilirubin increased
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
1/27 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Investigations
C-reactive protein increased
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Investigations
Liver function test increased
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Investigations
Neutrophil count decreased
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Investigations
Platelet count decreased
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.1%
2/184 • Number of events 2 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal metastasis
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraneoplastic syndrome
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Nervous system disorders
Cerebral infarction
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Nervous system disorders
Dizziness
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
1/27 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Nervous system disorders
Seizure
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.6%
3/184 • Number of events 3 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
1/27 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.6%
2/55 • Number of events 2 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Renal and urinary disorders
Renal failure
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Renal and urinary disorders
Renal injury
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.2%
4/184 • Number of events 4 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
2.1%
4/190 • Number of events 4 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Respiratory, thoracic and mediastinal disorders
Malignant pleural effusion
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.3%
6/184 • Number of events 6 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
11.1%
3/27 • Number of events 3 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
4.2%
8/190 • Number of events 8 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary venous thrombosis
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
1/27 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Skin and subcutaneous tissue disorders
Dermatomyositis
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Vascular disorders
Capillary leak syndrome
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Vascular disorders
Hypertension
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Vascular disorders
Lymphocele
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Vascular disorders
Vasculitis
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Vascular disorders
Vena cava thrombosis
|
0.54%
1/184 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
Other adverse events
| Measure |
Nemvaleukin 6 mcg/kg and Pembrolizumab 200 mg
n=184 participants at risk
Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles and Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
|
Pembrolizumab 200 mg
n=27 participants at risk
Participants received Pembrolizumab 200 mg IV infusion over 30 minutes on Day 1 of 21-day cycles.
|
Nemvaleukin 6 mcg/kg
n=55 participants at risk
Participants received Nemvaleukin 6 mcg/kg/day IV infusion over 30 minutes on Days 1 through 5 of 21-day cycles.
|
Investigator's Choice Chemotherapy
n=190 participants at risk
Investigator's choice chemotherapy includes one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator pre-selected the Investigator's choice treatment before the randomization of each participant.
Pegylated Liposomal Doxorubicin (PLD): 40 mg/m\^2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+).
Paclitaxel: 80 mg/m\^2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min.
Topotecan: 4 mg/m\^2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min.
Gemcitabine: 1,000 mg/m\^2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
28.8%
53/184 • Number of events 102 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
11.1%
3/27 • Number of events 3 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
27.3%
15/55 • Number of events 31 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
33.7%
64/190 • Number of events 165 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.8%
7/184 • Number of events 23 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
1/27 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
12.7%
7/55 • Number of events 30 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
5.3%
10/190 • Number of events 38 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
14.7%
27/184 • Number of events 60 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
9.1%
5/55 • Number of events 12 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.6%
3/190 • Number of events 3 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Blood and lymphatic system disorders
Neutropenia
|
28.8%
53/184 • Number of events 180 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
29.1%
16/55 • Number of events 65 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
31.6%
60/190 • Number of events 158 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
13.6%
25/184 • Number of events 56 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
1/27 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
14.5%
8/55 • Number of events 16 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
18.4%
35/190 • Number of events 110 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Cardiac disorders
Sinus tachycardia
|
2.2%
4/184 • Number of events 5 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
9.1%
5/55 • Number of events 6 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.6%
3/190 • Number of events 3 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Gastrointestinal disorders
Abdominal distension
|
9.2%
17/184 • Number of events 21 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
5.5%
3/55 • Number of events 3 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
7.4%
14/190 • Number of events 14 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Gastrointestinal disorders
Abdominal pain
|
19.0%
35/184 • Number of events 40 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
14.8%
4/27 • Number of events 4 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
23.6%
13/55 • Number of events 18 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
13.7%
26/190 • Number of events 28 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.4%
10/184 • Number of events 13 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
1/27 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
4.7%
9/190 • Number of events 11 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Gastrointestinal disorders
Ascites
|
6.0%
11/184 • Number of events 16 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
1/27 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
10.9%
6/55 • Number of events 11 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
4.2%
8/190 • Number of events 11 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Gastrointestinal disorders
Constipation
|
19.0%
35/184 • Number of events 45 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
7.4%
2/27 • Number of events 2 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
21.8%
12/55 • Number of events 16 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
15.8%
30/190 • Number of events 40 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Gastrointestinal disorders
Diarrhoea
|
22.3%
41/184 • Number of events 55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
11.1%
3/27 • Number of events 3 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
16.4%
9/55 • Number of events 16 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
17.4%
33/190 • Number of events 52 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Gastrointestinal disorders
Dry mouth
|
4.3%
8/184 • Number of events 8 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
5.5%
3/55 • Number of events 3 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Gastrointestinal disorders
Nausea
|
38.6%
71/184 • Number of events 101 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
11.1%
3/27 • Number of events 3 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
36.4%
20/55 • Number of events 36 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
33.2%
63/190 • Number of events 81 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Gastrointestinal disorders
Stomatitis
|
4.3%
8/184 • Number of events 11 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
5.8%
11/190 • Number of events 13 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Gastrointestinal disorders
Vomiting
|
24.5%
45/184 • Number of events 69 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
1/27 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
40.0%
22/55 • Number of events 32 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
14.7%
28/190 • Number of events 37 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
General disorders
Asthenia
|
20.1%
37/184 • Number of events 50 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
27.3%
15/55 • Number of events 31 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
22.6%
43/190 • Number of events 75 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
General disorders
Chills
|
33.2%
61/184 • Number of events 162 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
1/27 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
27.3%
15/55 • Number of events 30 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.1%
2/190 • Number of events 2 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
General disorders
Fatigue
|
27.7%
51/184 • Number of events 80 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
14.8%
4/27 • Number of events 4 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
23.6%
13/55 • Number of events 15 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
22.6%
43/190 • Number of events 64 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
General disorders
Mucosal inflammation
|
1.6%
3/184 • Number of events 3 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.6%
2/55 • Number of events 2 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
5.8%
11/190 • Number of events 18 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
General disorders
Oedema peripheral
|
15.2%
28/184 • Number of events 35 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
1/27 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
10.9%
6/55 • Number of events 6 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
7.4%
14/190 • Number of events 15 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
General disorders
Pyrexia
|
44.0%
81/184 • Number of events 193 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
1/27 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
34.5%
19/55 • Number of events 60 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
6.8%
13/190 • Number of events 14 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Immune system disorders
Cytokine release syndrome
|
20.1%
37/184 • Number of events 176 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
18.2%
10/55 • Number of events 29 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/190 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Infections and infestations
COVID-19
|
6.0%
11/184 • Number of events 11 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
2.1%
4/190 • Number of events 4 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
13/184 • Number of events 15 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
14.8%
4/27 • Number of events 4 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
7.3%
4/55 • Number of events 4 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
5.3%
10/190 • Number of events 13 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
16.8%
31/184 • Number of events 88 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
21.8%
12/55 • Number of events 37 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Investigations
Alanine aminotransferase increased
|
28.3%
52/184 • Number of events 94 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
7.4%
2/27 • Number of events 2 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
36.4%
20/55 • Number of events 53 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
7.4%
14/190 • Number of events 22 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Investigations
Aspartate aminotransferase increased
|
33.7%
62/184 • Number of events 116 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
1/27 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
38.2%
21/55 • Number of events 56 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
7.9%
15/190 • Number of events 16 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Investigations
Blood alkaline phosphatase increased
|
9.8%
18/184 • Number of events 29 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
7.4%
2/27 • Number of events 2 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
18.2%
10/55 • Number of events 15 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
2.6%
5/190 • Number of events 6 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Investigations
Blood bilirubin increased
|
2.2%
4/184 • Number of events 6 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
10.9%
6/55 • Number of events 11 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Investigations
Blood creatinine increased
|
4.9%
9/184 • Number of events 13 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
1/27 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
5.5%
3/55 • Number of events 6 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
2.1%
4/190 • Number of events 12 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.6%
14/184 • Number of events 30 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
1/27 • Number of events 2 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
16.4%
9/55 • Number of events 39 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
2.6%
5/190 • Number of events 5 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Investigations
White blood cell count decreased
|
7.1%
13/184 • Number of events 34 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
7.3%
4/55 • Number of events 11 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
6.3%
12/190 • Number of events 21 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.8%
31/184 • Number of events 36 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
18.2%
10/55 • Number of events 13 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
12.6%
24/190 • Number of events 30 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.1%
2/184 • Number of events 3 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
1/27 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
5.5%
3/55 • Number of events 5 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.6%
3/190 • Number of events 5 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
9.2%
17/184 • Number of events 32 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
1/27 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
10.9%
6/55 • Number of events 14 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
2.6%
5/190 • Number of events 5 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.0%
11/184 • Number of events 16 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
1/27 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
9.1%
5/55 • Number of events 8 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
5.8%
11/190 • Number of events 12 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
8.7%
16/184 • Number of events 25 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
7.4%
2/27 • Number of events 4 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.6%
2/55 • Number of events 3 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
6.8%
13/190 • Number of events 28 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.8%
7/184 • Number of events 13 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
1/27 • Number of events 2 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
9.1%
5/55 • Number of events 12 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.2%
6/190 • Number of events 6 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.0%
11/184 • Number of events 13 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.6%
2/55 • Number of events 3 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.1%
2/190 • Number of events 3 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.2%
15/184 • Number of events 19 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
14.8%
4/27 • Number of events 4 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
9.1%
5/55 • Number of events 5 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
4.7%
9/190 • Number of events 12 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.5%
12/184 • Number of events 14 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
1/27 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
7.3%
4/55 • Number of events 4 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
6.3%
12/190 • Number of events 14 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.3%
19/184 • Number of events 22 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
7.3%
4/55 • Number of events 4 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
5.3%
10/190 • Number of events 10 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Nervous system disorders
Dizziness
|
8.2%
15/184 • Number of events 22 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
1/27 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
9.1%
5/55 • Number of events 7 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
7/190 • Number of events 8 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Nervous system disorders
Headache
|
13.6%
25/184 • Number of events 31 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
1/27 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
16.4%
9/55 • Number of events 12 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
6.8%
13/190 • Number of events 16 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/184 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
10.0%
19/190 • Number of events 24 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Psychiatric disorders
Insomnia
|
3.8%
7/184 • Number of events 7 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.6%
2/55 • Number of events 2 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
6.3%
12/190 • Number of events 13 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.2%
4/184 • Number of events 5 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
5.5%
3/55 • Number of events 3 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.53%
1/190 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.5%
12/184 • Number of events 13 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
7.4%
2/27 • Number of events 2 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.8%
1/55 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
4.7%
9/190 • Number of events 11 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.7%
27/184 • Number of events 40 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
18.5%
5/27 • Number of events 7 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
5.5%
3/55 • Number of events 4 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
11.1%
21/190 • Number of events 29 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.7%
5/184 • Number of events 5 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
4.7%
9/190 • Number of events 10 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.6%
3/184 • Number of events 6 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
1/27 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
5.5%
3/55 • Number of events 3 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
7/190 • Number of events 9 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.6%
3/184 • Number of events 3 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
11.1%
21/190 • Number of events 24 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.2%
15/184 • Number of events 18 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
7/190 • Number of events 9 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.9%
9/184 • Number of events 9 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
1/27 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.6%
2/55 • Number of events 2 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
6.3%
12/190 • Number of events 15 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.9%
9/184 • Number of events 20 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/27 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
0.00%
0/55 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
2.1%
4/190 • Number of events 4 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Vascular disorders
Hypertension
|
5.4%
10/184 • Number of events 35 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
1/27 • Number of events 3 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
5.5%
3/55 • Number of events 3 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
2.1%
4/190 • Number of events 4 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
|
Vascular disorders
Hypotension
|
7.1%
13/184 • Number of events 32 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
3.7%
1/27 • Number of events 1 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
9.1%
5/55 • Number of events 5 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
1.1%
2/190 • Number of events 2 • From first dose of study drug up to 90 days after last dose (up to 23 months)
ITT set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place