Trial Outcomes & Findings for Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2). (NCT NCT04472429)
NCT ID: NCT04472429
Last Updated: 2025-11-03
Results Overview
PFS was defined as the time from the date of randomization to the date of the first documented disease progression (PD), according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review committee (BICR), or death due to any cause, whichever occurred first. PD: progression of a target or non-target lesion or presence of a new lesion.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
308 participants
Primary outcome timeframe
up to 33.9 months
Results posted on
2025-11-03
Participant Flow
This study randomized participants at 70 study centers in Australia, Belgium, Germany, Denmark, Spain, France, the United Kingdom, Italy, Japan, Norway, Puerto Rico, Sweden, and the United States. This report contains data collected through a cutoff date of 15 April 2024.
Participant milestones
| Measure |
Retifanlimab 500 mg Q4W + Chemotherapy
Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared \[mg/m\^2\] on Days 1, 8, and 15).
|
Retifanlimab 500 mg Q4W
In the optional monotherapy treatment period, participants randomized to placebo + chemotherapy who experienced documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) verified by the blinded independent review committee (BICR) had the opportunity to receive open-label retifanlimab monotherapy for up to thirteen 28-day cycles (1 year).
|
Placebo + Chemotherapy
Participants received matching placebo Q4W for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason.
|
|---|---|---|---|
|
Randomized Period
STARTED
|
154
|
0
|
154
|
|
Randomized Period
Received Study Treatment
|
154
|
0
|
152
|
|
Randomized Period
COMPLETED
|
0
|
0
|
69
|
|
Randomized Period
NOT COMPLETED
|
154
|
0
|
85
|
|
Open-label Monotherapy Period
STARTED
|
0
|
69
|
0
|
|
Open-label Monotherapy Period
COMPLETED
|
0
|
0
|
0
|
|
Open-label Monotherapy Period
NOT COMPLETED
|
0
|
69
|
0
|
Reasons for withdrawal
| Measure |
Retifanlimab 500 mg Q4W + Chemotherapy
Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared \[mg/m\^2\] on Days 1, 8, and 15).
|
Retifanlimab 500 mg Q4W
In the optional monotherapy treatment period, participants randomized to placebo + chemotherapy who experienced documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) verified by the blinded independent review committee (BICR) had the opportunity to receive open-label retifanlimab monotherapy for up to thirteen 28-day cycles (1 year).
|
Placebo + Chemotherapy
Participants received matching placebo Q4W for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason.
|
|---|---|---|---|
|
Randomized Period
Ongoing
|
90
|
0
|
40
|
|
Randomized Period
Death
|
52
|
0
|
37
|
|
Randomized Period
Lost to Follow-up
|
4
|
0
|
0
|
|
Randomized Period
Physician Decision
|
1
|
0
|
2
|
|
Randomized Period
Withdrawal by Subject
|
6
|
0
|
5
|
|
Randomized Period
Inclusion Criterion Not Met on Day of Planned Dose
|
0
|
0
|
1
|
|
Randomized Period
New Diagnosis of Lymphoma
|
1
|
0
|
0
|
|
Open-label Monotherapy Period
Ongoing
|
0
|
32
|
0
|
|
Open-label Monotherapy Period
Death
|
0
|
35
|
0
|
|
Open-label Monotherapy Period
Lost to Follow-up
|
0
|
2
|
0
|
Baseline Characteristics
Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).
Baseline characteristics by cohort
| Measure |
Retifanlimab 500 mg Q4W + Chemotherapy
n=154 Participants
Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared \[mg/m\^2\] on Days 1, 8, and 15).
|
Placebo + Chemotherapy
n=154 Participants
Participants received matching placebo Q4W for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason.
|
Total
n=308 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
129 Participants
n=3 Participants
|
132 Participants
n=15 Participants
|
261 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
5 Participants
n=3 Participants
|
3 Participants
n=15 Participants
|
8 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
10 Participants
n=3 Participants
|
11 Participants
n=15 Participants
|
21 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=3 Participants
|
2 Participants
n=15 Participants
|
2 Participants
n=18 Participants
|
|
Age, Continuous
|
61.6 years
STANDARD_DEVIATION 9.81 • n=3 Participants
|
61.1 years
STANDARD_DEVIATION 10.51 • n=15 Participants
|
61.3 years
STANDARD_DEVIATION 10.15 • n=18 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=3 Participants
|
118 Participants
n=15 Participants
|
222 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=3 Participants
|
36 Participants
n=15 Participants
|
86 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
132 Participants
n=3 Participants
|
137 Participants
n=15 Participants
|
269 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Black/African-American
|
3 Participants
n=3 Participants
|
2 Participants
n=15 Participants
|
5 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Asian
|
10 Participants
n=3 Participants
|
8 Participants
n=15 Participants
|
18 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Multiple Races
|
1 Participants
n=3 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Mexican
|
0 Participants
n=3 Participants
|
1 Participants
n=15 Participants
|
1 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Mixed: White/Indian
|
0 Participants
n=3 Participants
|
1 Participants
n=15 Participants
|
1 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
White or Other
|
1 Participants
n=3 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
White British
|
1 Participants
n=3 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Captured as "Other" in Database
|
1 Participants
n=3 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
13 Participants
n=3 Participants
|
8 Participants
n=15 Participants
|
21 Participants
n=18 Participants
|
PRIMARY outcome
Timeframe: up to 33.9 monthsPopulation: Full Analysis Set: all randomized participants. Participants were analyzed according to the treatment and strata they had been assigned during randomization. Median PFS time was estimated using the Kaplan-Meier method. The confidence interval for median PFS time was calculated using the method of Brookmeyer and Crowley.
PFS was defined as the time from the date of randomization to the date of the first documented disease progression (PD), according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review committee (BICR), or death due to any cause, whichever occurred first. PD: progression of a target or non-target lesion or presence of a new lesion.
Outcome measures
| Measure |
Retifanlimab 500 mg Q4W
In the optional monotherapy treatment period, participants randomized to placebo + chemotherapy who experienced documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) verified by the blinded independent review committee (BICR) had the opportunity to receive open-label retifanlimab monotherapy for up to thirteen 28-day cycles (1 year).
|
Retifanlimab 500 mg Q4W + Chemotherapy
n=154 Participants
Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared \[mg/m\^2\] on Days 1, 8, and 15).
|
Placebo + Chemotherapy
n=154 Participants
Participants received matching placebo Q4W for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason.
|
|---|---|---|---|
|
Progression-free Survival (PFS)
|
—
|
9.3 months
Interval 7.5 to 11.3
|
7.4 months
Interval 7.1 to 7.7
|
SECONDARY outcome
Timeframe: up to 40.4 monthsOverall survival was defined as the time from the date of randomization until the date of death due to any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 445 daysORR was defined as the percentage of participants with a CR or PR at any post-Baseline visit before the first PD or new anticancer therapy, according to RECIST v1.1 as determined by BICR. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 32.1 monthsDOR was defined as the time from the first documented response (CR or PR) determined by BICR to the time of first documented disease progression per RECIST v1.1 or death due to any cause. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 445 daysDCR was defined as the percentage of participants maintaining either a confirmed overall response of CR or PR or stable disease (SD) at any post-Baseline visit before the first PD or new anticancer therapy, according to RECIST v1.1 as determined by BICR. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 535 daysPopulation: Safety Population: all randomized participants who received at least 1 dose of study treatment. Treatment groups for this population were determined according to the actual treatment the participant received regardless of treatment assignment at randomization.
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of a pre-existing events after the first dose of study treatment and within 90 days of the last administration of retifanlimab/placebo, or within 30 days of the last chemotherapy. AEs that occurred after new anticancer therapy were be excluded.
Outcome measures
| Measure |
Retifanlimab 500 mg Q4W
In the optional monotherapy treatment period, participants randomized to placebo + chemotherapy who experienced documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) verified by the blinded independent review committee (BICR) had the opportunity to receive open-label retifanlimab monotherapy for up to thirteen 28-day cycles (1 year).
|
Retifanlimab 500 mg Q4W + Chemotherapy
n=154 Participants
Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared \[mg/m\^2\] on Days 1, 8, and 15).
|
Placebo + Chemotherapy
n=152 Participants
Participants received matching placebo Q4W for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason.
|
|---|---|---|---|
|
Number of Participants With Any Treatment-emergent Adverse Event (TEAE ) During the Randomized Period
|
—
|
154 Participants
|
152 Participants
|
SECONDARY outcome
Timeframe: up to 535 daysPopulation: Safety Population
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of a pre-existing events after the first dose of study treatment and within 90 days of the last administration of retifanlimab/placebo, or within 30 days of the last chemotherapy. AEs that occurred after new anticancer therapy were be excluded.
Outcome measures
| Measure |
Retifanlimab 500 mg Q4W
In the optional monotherapy treatment period, participants randomized to placebo + chemotherapy who experienced documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) verified by the blinded independent review committee (BICR) had the opportunity to receive open-label retifanlimab monotherapy for up to thirteen 28-day cycles (1 year).
|
Retifanlimab 500 mg Q4W + Chemotherapy
n=154 Participants
Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared \[mg/m\^2\] on Days 1, 8, and 15).
|
Placebo + Chemotherapy
n=152 Participants
Participants received matching placebo Q4W for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason.
|
|---|---|---|---|
|
Number of Participants With Any TEAE Leading to Discontinuation of Study Drug During the Randomized Period
|
—
|
17 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: up 457 daysAn AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of a pre-existing events after the first dose of study treatment and within 90 days of the last administration of retifanlimab/placebo, or within 30 days of the last chemotherapy. AEs that occurred after new anticancer therapy were be excluded.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up 457 daysAn AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of a pre-existing events after the first dose of study treatment and within 90 days of the last administration of retifanlimab/placebo, or within 30 days of the last chemotherapy. AEs that occurred after new anticancer therapy were be excluded.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: preinfusion on Day 1 of Cycles 1, 2, 4, 6, 8, and 12; immediately after infusion on Day 1 of Cycles 1 and 4Population: Pharmacokinetic (PK) Evaluable Population: all participants who received at least 1 dose of study treatment and provided at least 1 postdose plasma sample
Cmax was defined as the maximum observed plasma concentration of retifanlimab.
Outcome measures
| Measure |
Retifanlimab 500 mg Q4W
In the optional monotherapy treatment period, participants randomized to placebo + chemotherapy who experienced documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) verified by the blinded independent review committee (BICR) had the opportunity to receive open-label retifanlimab monotherapy for up to thirteen 28-day cycles (1 year).
|
Retifanlimab 500 mg Q4W + Chemotherapy
n=150 Participants
Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared \[mg/m\^2\] on Days 1, 8, and 15).
|
Placebo + Chemotherapy
Participants received matching placebo Q4W for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason.
|
|---|---|---|---|
|
Cmax of Retifanlimab at Steady State When Administered With Carboplatin-paclitaxel
|
—
|
209 milligrams per liter (mg/L)
Geometric Coefficient of Variation 27.9
|
—
|
SECONDARY outcome
Timeframe: preinfusion on Day 1 of Cycles 1, 2, 4, 6, 8, and 12; immediately after infusion on Day 1 of Cycles 1 and 4Population: PK Evaluable Population
Cmin was defined as the minimum observed plasma concentration of retifanlimab.
Outcome measures
| Measure |
Retifanlimab 500 mg Q4W
In the optional monotherapy treatment period, participants randomized to placebo + chemotherapy who experienced documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) verified by the blinded independent review committee (BICR) had the opportunity to receive open-label retifanlimab monotherapy for up to thirteen 28-day cycles (1 year).
|
Retifanlimab 500 mg Q4W + Chemotherapy
n=150 Participants
Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared \[mg/m\^2\] on Days 1, 8, and 15).
|
Placebo + Chemotherapy
Participants received matching placebo Q4W for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason.
|
|---|---|---|---|
|
Cmin of Retifanlimab at Steady State When Administered With Carboplatin-paclitaxel
|
—
|
49.5 mg/L
Geometric Coefficient of Variation 59.4
|
—
|
SECONDARY outcome
Timeframe: preinfusion on Day 1 of Cycles 1, 2, 4, 6, 8, and 12; immediately after infusion on Day 1 of Cycles 1 and 4Population: PK Evaluable Population
tmax was defined as the time to the maximum serum concentration of retifanlimab.
Outcome measures
| Measure |
Retifanlimab 500 mg Q4W
In the optional monotherapy treatment period, participants randomized to placebo + chemotherapy who experienced documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) verified by the blinded independent review committee (BICR) had the opportunity to receive open-label retifanlimab monotherapy for up to thirteen 28-day cycles (1 year).
|
Retifanlimab 500 mg Q4W + Chemotherapy
n=150 Participants
Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared \[mg/m\^2\] on Days 1, 8, and 15).
|
Placebo + Chemotherapy
Participants received matching placebo Q4W for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason.
|
|---|---|---|---|
|
Tmax of Retifanlimab at Steady State When Administered With Carboplatin-paclitaxel
|
—
|
0.720 hours
Geometric Coefficient of Variation 35.8
|
—
|
SECONDARY outcome
Timeframe: preinfusion on Day 1 of Cycles 1, 2, 4, 6, 8, and 12; immediately after infusion on Day 1 of Cycles 1 and 4Population: PK Evaluable Population
AUC was defined as the area under the serum concentration versus time curve.
Outcome measures
| Measure |
Retifanlimab 500 mg Q4W
In the optional monotherapy treatment period, participants randomized to placebo + chemotherapy who experienced documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) verified by the blinded independent review committee (BICR) had the opportunity to receive open-label retifanlimab monotherapy for up to thirteen 28-day cycles (1 year).
|
Retifanlimab 500 mg Q4W + Chemotherapy
n=150 Participants
Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared \[mg/m\^2\] on Days 1, 8, and 15).
|
Placebo + Chemotherapy
Participants received matching placebo Q4W for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason.
|
|---|---|---|---|
|
AUC of Retifanlimab at Steady State When Administered With Carboplatin-paclitaxel
|
—
|
2490 day x mg/L
Geometric Coefficient of Variation 40.1
|
—
|
Adverse Events
Placebo + Chemotherapy
Serious events: 59 serious events
Other events: 151 other events
Deaths: 38 deaths
Retifanlimab 500 mg Q4W + Chemotherapy
Serious events: 73 serious events
Other events: 154 other events
Deaths: 53 deaths
Randomized Period Total
Serious events: 132 serious events
Other events: 305 other events
Deaths: 91 deaths
Retifanlimab 500 mg Q4W
Serious events: 16 serious events
Other events: 48 other events
Deaths: 35 deaths
Serious adverse events
| Measure |
Placebo + Chemotherapy
n=152 participants at risk
Participants received matching placebo Q4W for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason.
|
Retifanlimab 500 mg Q4W + Chemotherapy
n=154 participants at risk
Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared \[mg/m\^2\] on Days 1, 8, and 15).
|
Randomized Period Total
n=306 participants at risk
Randomized Period Total
|
Retifanlimab 500 mg Q4W
n=69 participants at risk
In the optional monotherapy treatment period, participants randomized to placebo + chemotherapy who experienced documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) verified by the blinded independent review committee (BICR) had the opportunity to receive open-label retifanlimab monotherapy for up to thirteen 28-day cycles (1 year).
|
|---|---|---|---|---|
|
Infections and infestations
Anal infection
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Appendicitis
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Asthenia
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
2/306 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Ataxia
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Atrial flutter
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Abdominal infection
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
2/152 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
2/306 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
2.9%
2/69 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.3%
2/152 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.3%
2/154 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.3%
4/306 • Number of events 4 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.3%
2/154 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
2/306 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
2/152 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.9%
3/154 • Number of events 3 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.6%
5/306 • Number of events 5 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Anal abscess
|
2.0%
3/152 • Number of events 3 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.98%
3/306 • Number of events 3 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Anal fistula
|
1.3%
2/152 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
2/306 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Cell death
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Central nervous system lesion
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Device related infection
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
4/152 • Number of events 4 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
2.6%
4/154 • Number of events 4 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
2.6%
8/306 • Number of events 8 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.3%
2/152 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
2/306 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/306 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/306 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood bilirubin increased
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
2/306 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood creatinine increased
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
COVID-19
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.3%
2/154 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
2/306 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
2/306 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Embolism
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Erysipelas
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
2/306 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.66%
1/152 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
2/306 • Number of events 3 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Fatigue
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.3%
2/152 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.3%
2/154 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.3%
4/306 • Number of events 4 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
General physical health deterioration
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
2/306 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/306 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Headache
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Hydronephrosis
|
1.3%
2/152 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.98%
3/306 • Number of events 3 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Hyperaesthesia
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.3%
2/152 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
2/306 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/306 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/306 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Immune-mediated cholangitis
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
2/306 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Inadequate analgesia
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Infected fistula
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Necrosis ischaemic
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Neutropenic colitis
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Neutropenic sepsis
|
1.3%
2/152 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.3%
2/154 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.3%
4/306 • Number of events 4 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
2/306 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumonia haemophilus
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Rectal perforation
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Renal impairment
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Endocrine disorders
Secondary adrenocortical insufficiency
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Sepsis
|
2.6%
4/152 • Number of events 4 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
3.2%
5/154 • Number of events 5 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
2.9%
9/306 • Number of events 9 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
2.9%
2/69 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Skin infection
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.66%
1/152 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Urethral fistula
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
3.3%
5/152 • Number of events 6 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.3%
2/154 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
2.3%
7/306 • Number of events 8 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
3/152 • Number of events 4 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
2.6%
4/154 • Number of events 4 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
2.3%
7/306 • Number of events 8 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Orchitis
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Pain
|
0.66%
1/152 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
2.6%
4/152 • Number of events 4 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.6%
5/306 • Number of events 6 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Confusional state
|
0.66%
1/152 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
2/306 • Number of events 3 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Creatinine renal clearance decreased
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/306 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
1.3%
2/152 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.98%
3/306 • Number of events 3 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Fungating wound
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/306 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Infection
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Inflammation
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Influenza like illness
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Jaundice
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Klebsiella infection
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
2/306 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Large intestine infection
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Lipase increased
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.3%
2/154 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
2/306 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Lymph node haemorrhage
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Lymphocele
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Lymphoedema
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
2/306 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Melaena
|
0.66%
1/152 • Number of events 3 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 3 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Myasthenic syndrome
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.9%
3/154 • Number of events 3 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.98%
3/306 • Number of events 3 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
1.3%
2/152 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
2/306 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
3.2%
5/154 • Number of events 5 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
2.0%
6/306 • Number of events 6 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pyelonephritis
|
2.0%
3/152 • Number of events 4 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.98%
3/306 • Number of events 4 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
2.9%
2/69 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Pyrexia
|
2.0%
3/152 • Number of events 3 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.9%
3/154 • Number of events 3 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
2.0%
6/306 • Number of events 6 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.3%
2/154 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
2/306 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.3%
2/154 • Number of events 3 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
2/306 • Number of events 3 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour fistulisation
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/154 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/306 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Warm autoimmune haemolytic anaemia
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/152 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.33%
1/306 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Wound infection
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
2/306 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
Other adverse events
| Measure |
Placebo + Chemotherapy
n=152 participants at risk
Participants received matching placebo Q4W for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason.
|
Retifanlimab 500 mg Q4W + Chemotherapy
n=154 participants at risk
Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared \[mg/m\^2\] on Days 1, 8, and 15).
|
Randomized Period Total
n=306 participants at risk
Randomized Period Total
|
Retifanlimab 500 mg Q4W
n=69 participants at risk
In the optional monotherapy treatment period, participants randomized to placebo + chemotherapy who experienced documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) verified by the blinded independent review committee (BICR) had the opportunity to receive open-label retifanlimab monotherapy for up to thirteen 28-day cycles (1 year).
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
11.2%
17/152 • Number of events 21 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
11.7%
18/154 • Number of events 19 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
11.4%
35/306 • Number of events 40 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
5.8%
4/69 • Number of events 5 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.2%
17/152 • Number of events 24 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
9.1%
14/154 • Number of events 18 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
10.1%
31/306 • Number of events 42 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
4.6%
7/152 • Number of events 9 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
10.4%
16/154 • Number of events 21 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
7.5%
23/306 • Number of events 30 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
4.3%
3/69 • Number of events 3 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
49.3%
75/152 • Number of events 76 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
51.3%
79/154 • Number of events 83 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
50.3%
154/306 • Number of events 159 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
69.1%
105/152 • Number of events 170 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
66.2%
102/154 • Number of events 171 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
67.6%
207/306 • Number of events 341 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
10.1%
7/69 • Number of events 8 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Anxiety
|
6.6%
10/152 • Number of events 11 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
5.8%
9/154 • Number of events 12 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
6.2%
19/306 • Number of events 23 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.8%
21/152 • Number of events 28 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
15.6%
24/154 • Number of events 29 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
14.7%
45/306 • Number of events 57 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
5.8%
4/69 • Number of events 4 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
6.6%
10/152 • Number of events 12 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
8.4%
13/154 • Number of events 18 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
7.5%
23/306 • Number of events 30 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
7.2%
5/69 • Number of events 6 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Asthenia
|
39.5%
60/152 • Number of events 101 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
47.4%
73/154 • Number of events 108 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
43.5%
133/306 • Number of events 209 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
13.0%
9/69 • Number of events 10 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.2%
20/152 • Number of events 24 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
10.4%
16/154 • Number of events 17 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
11.8%
36/306 • Number of events 41 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
2.9%
2/69 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
3.9%
6/152 • Number of events 6 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
5.8%
9/154 • Number of events 12 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
4.9%
15/306 • Number of events 18 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood creatinine increased
|
0.66%
1/152 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
5.2%
8/154 • Number of events 10 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
2.9%
9/306 • Number of events 12 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
4.3%
3/69 • Number of events 3 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
COVID-19
|
12.5%
19/152 • Number of events 19 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
13.0%
20/154 • Number of events 21 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
12.7%
39/306 • Number of events 40 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
4.3%
3/69 • Number of events 3 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
40.1%
61/152 • Number of events 85 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
35.7%
55/154 • Number of events 73 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
37.9%
116/306 • Number of events 158 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
15.9%
11/69 • Number of events 13 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.5%
16/152 • Number of events 20 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
11.0%
17/154 • Number of events 22 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
10.8%
33/306 • Number of events 42 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
2.9%
2/69 • Number of events 3 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.7%
39/152 • Number of events 53 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
24.0%
37/154 • Number of events 44 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
24.8%
76/306 • Number of events 97 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
10.1%
7/69 • Number of events 7 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
40.1%
61/152 • Number of events 104 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
48.1%
74/154 • Number of events 158 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
44.1%
135/306 • Number of events 262 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
11.6%
8/69 • Number of events 10 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
5.9%
9/152 • Number of events 10 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.9%
3/154 • Number of events 4 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
3.9%
12/306 • Number of events 14 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Headache
|
10.5%
16/152 • Number of events 31 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
16.2%
25/154 • Number of events 29 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
13.4%
41/306 • Number of events 60 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Hypertension
|
7.2%
11/152 • Number of events 17 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
7.1%
11/154 • Number of events 17 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
7.2%
22/306 • Number of events 34 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
0.66%
1/152 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
7.8%
12/154 • Number of events 12 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
4.2%
13/306 • Number of events 13 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
4.3%
3/69 • Number of events 3 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.9%
6/152 • Number of events 6 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
6.5%
10/154 • Number of events 11 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
5.2%
16/306 • Number of events 17 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.9%
12/152 • Number of events 20 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
12.3%
19/154 • Number of events 24 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
10.1%
31/306 • Number of events 44 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
4.3%
3/69 • Number of events 4 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
10.5%
16/152 • Number of events 19 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
8.4%
13/154 • Number of events 18 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
9.5%
29/306 • Number of events 37 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
2.9%
2/69 • Number of events 3 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
6.6%
10/152 • Number of events 11 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
7.1%
11/154 • Number of events 11 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
6.9%
21/306 • Number of events 22 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.9%
6/152 • Number of events 6 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
6.5%
10/154 • Number of events 11 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
5.2%
16/306 • Number of events 17 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Dysgeusia
|
8.6%
13/152 • Number of events 14 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
13.0%
20/154 • Number of events 21 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
10.8%
33/306 • Number of events 35 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.3%
5/152 • Number of events 5 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
5.2%
8/154 • Number of events 9 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
4.2%
13/306 • Number of events 14 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.8%
18/152 • Number of events 20 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
14.9%
23/154 • Number of events 25 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
13.4%
41/306 • Number of events 45 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
2.9%
2/69 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Dysuria
|
3.3%
5/152 • Number of events 5 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
3.9%
6/154 • Number of events 7 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
3.6%
11/306 • Number of events 12 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
5.8%
4/69 • Number of events 5 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.0%
3/152 • Number of events 3 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
5.2%
8/154 • Number of events 9 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
3.6%
11/306 • Number of events 12 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.6%
7/152 • Number of events 7 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
9.1%
14/154 • Number of events 16 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
6.9%
21/306 • Number of events 23 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Fatigue
|
32.9%
50/152 • Number of events 80 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
29.2%
45/154 • Number of events 56 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
31.0%
95/306 • Number of events 136 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
7.2%
5/69 • Number of events 5 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.0%
3/152 • Number of events 3 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
5.8%
9/154 • Number of events 12 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
3.9%
12/306 • Number of events 15 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.9%
6/152 • Number of events 6 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
5.8%
9/154 • Number of events 9 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
4.9%
15/306 • Number of events 15 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
5.8%
4/69 • Number of events 4 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.3%
8/152 • Number of events 8 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
7.8%
12/154 • Number of events 15 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
6.5%
20/306 • Number of events 23 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
3.3%
5/152 • Number of events 5 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
13.6%
21/154 • Number of events 23 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
8.5%
26/306 • Number of events 28 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
11.6%
8/69 • Number of events 8 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
6.6%
10/152 • Number of events 12 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
5.2%
8/154 • Number of events 8 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
5.9%
18/306 • Number of events 20 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
4.3%
3/69 • Number of events 3 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.9%
9/152 • Number of events 14 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
11.0%
17/154 • Number of events 30 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
8.5%
26/306 • Number of events 44 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Mucosal inflammation
|
5.9%
9/152 • Number of events 12 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
11.0%
17/154 • Number of events 18 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
8.5%
26/306 • Number of events 30 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Neutrophil count decreased
|
22.4%
34/152 • Number of events 72 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
27.3%
42/154 • Number of events 104 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
24.8%
76/306 • Number of events 176 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Oedema peripheral
|
18.4%
28/152 • Number of events 33 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
13.6%
21/154 • Number of events 21 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
16.0%
49/306 • Number of events 54 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Pain
|
3.9%
6/152 • Number of events 7 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.65%
1/154 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
2.3%
7/306 • Number of events 8 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
5.8%
4/69 • Number of events 4 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Pyrexia
|
11.8%
18/152 • Number of events 28 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
13.6%
21/154 • Number of events 36 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
12.7%
39/306 • Number of events 64 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
10.1%
7/69 • Number of events 8 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.9%
12/152 • Number of events 21 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
15.6%
24/154 • Number of events 29 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
11.8%
36/306 • Number of events 50 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
2.9%
2/69 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
7.2%
11/152 • Number of events 13 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
11.0%
17/154 • Number of events 21 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
9.2%
28/306 • Number of events 34 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
2.9%
2/69 • Number of events 3 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Tachycardia
|
1.3%
2/152 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
5.8%
9/154 • Number of events 9 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
3.6%
11/306 • Number of events 11 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
20.4%
31/152 • Number of events 46 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
14.3%
22/154 • Number of events 38 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
17.3%
53/306 • Number of events 84 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
11.8%
18/152 • Number of events 25 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
10.4%
16/154 • Number of events 26 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
11.1%
34/306 • Number of events 51 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
4.3%
3/69 • Number of events 4 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.2%
17/152 • Number of events 29 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
13.0%
20/154 • Number of events 38 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
12.1%
37/306 • Number of events 67 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
19.7%
30/152 • Number of events 52 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
24.0%
37/154 • Number of events 50 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
21.9%
67/306 • Number of events 102 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
7.2%
5/69 • Number of events 6 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Weight decreased
|
8.6%
13/152 • Number of events 15 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
4.5%
7/154 • Number of events 7 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
6.5%
20/306 • Number of events 22 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
White blood cell count decreased
|
13.2%
20/152 • Number of events 50 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
15.6%
24/154 • Number of events 59 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
14.4%
44/306 • Number of events 109 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.2%
11/152 • Number of events 11 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
7.1%
11/154 • Number of events 14 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
7.2%
22/306 • Number of events 25 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
4.3%
3/69 • Number of events 3 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.9%
15/152 • Number of events 19 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
7.8%
12/154 • Number of events 18 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
8.8%
27/306 • Number of events 37 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
57.2%
87/152 • Number of events 151 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
55.2%
85/154 • Number of events 153 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
56.2%
172/306 • Number of events 304 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
5.8%
4/69 • Number of events 4 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
30.3%
46/152 • Number of events 51 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
29.9%
46/154 • Number of events 52 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
30.1%
92/306 • Number of events 103 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
4.3%
3/69 • Number of events 4 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Neurotoxicity
|
8.6%
13/152 • Number of events 13 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
5.8%
9/154 • Number of events 12 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
7.2%
22/306 • Number of events 25 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
44.1%
67/152 • Number of events 199 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
47.4%
73/154 • Number of events 184 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
45.8%
140/306 • Number of events 383 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
2.9%
2/69 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.6%
10/152 • Number of events 10 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
6.5%
10/154 • Number of events 12 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
6.5%
20/306 • Number of events 22 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
2.9%
2/69 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Paraesthesia
|
11.8%
18/152 • Number of events 23 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
16.2%
25/154 • Number of events 32 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
14.1%
43/306 • Number of events 55 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
2.9%
2/69 • Number of events 2 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
9.9%
15/152 • Number of events 15 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
11.0%
17/154 • Number of events 18 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
10.5%
32/306 • Number of events 33 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/69 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Platelet count decreased
|
9.9%
15/152 • Number of events 27 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
13.0%
20/154 • Number of events 52 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
11.4%
35/306 • Number of events 79 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Proctalgia
|
12.5%
19/152 • Number of events 21 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
9.1%
14/154 • Number of events 16 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
10.8%
33/306 • Number of events 37 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
1.4%
1/69 • Number of events 1 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.6%
10/152 • Number of events 10 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
24.0%
37/154 • Number of events 41 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
15.4%
47/306 • Number of events 51 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
5.8%
4/69 • Number of events 5 • up to approximately 33 months
Adverse events are reported for all randomized participants who received at least 1 dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
- Publication restrictions are in place
Restriction type: OTHER