Trial Outcomes & Findings for Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966) (NCT NCT04003636)
NCT ID: NCT04003636
Last Updated: 2026-03-24
Results Overview
Overall survival was defined as the time from randomization to death due to any cause.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1069 participants
Primary outcome timeframe
Up to approximately 38 months
Results posted on
2026-03-24
Participant Flow
Per protocol, response or progression during the second course treatment was not counted towards efficacy outcome measures, and adverse events during the second course treatment were not counted towards safety outcome measures.
Participant milestones
| Measure |
Arm A: Pembrolizumab + Chemotherapy
Participants received pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with Gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression.
|
Arm B: Placebo + Chemotherapy
Participants received Placebo to Pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles.
|
|---|---|---|
|
Overall Study
STARTED
|
533
|
536
|
|
Overall Study
Treated
|
529
|
534
|
|
Overall Study
Received a Second Course of Pembrolizumab
|
10
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
533
|
536
|
Reasons for withdrawal
| Measure |
Arm A: Pembrolizumab + Chemotherapy
Participants received pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with Gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression.
|
Arm B: Placebo + Chemotherapy
Participants received Placebo to Pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles.
|
|---|---|---|
|
Overall Study
Death
|
482
|
504
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
7
|
4
|
|
Overall Study
Sponsor decision
|
43
|
28
|
Baseline Characteristics
Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)
Baseline characteristics by cohort
| Measure |
Arm A: Pembrolizumab + Chemotherapy
n=533 Participants
Participants received pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with Gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression.
|
Arm B: Placebo + Chemotherapy
n=536 Participants
Participants received Placebo to Pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles.
|
Total
n=1069 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.3 Years
STANDARD_DEVIATION 10.3 • n=138 Participants
|
61.8 Years
STANDARD_DEVIATION 11.0 • n=62 Participants
|
62.5 Years
STANDARD_DEVIATION 10.7 • n=123 Participants
|
|
Sex: Female, Male
Female
|
253 Participants
n=138 Participants
|
264 Participants
n=62 Participants
|
517 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
280 Participants
n=138 Participants
|
272 Participants
n=62 Participants
|
552 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
59 Participants
n=138 Participants
|
52 Participants
n=62 Participants
|
111 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
433 Participants
n=138 Participants
|
449 Participants
n=62 Participants
|
882 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
41 Participants
n=138 Participants
|
35 Participants
n=62 Participants
|
76 Participants
n=123 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=138 Participants
|
1 Participants
n=62 Participants
|
3 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Asian
|
245 Participants
n=138 Participants
|
250 Participants
n=62 Participants
|
495 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=138 Participants
|
3 Participants
n=62 Participants
|
14 Participants
n=123 Participants
|
|
Race (NIH/OMB)
White
|
256 Participants
n=138 Participants
|
268 Participants
n=62 Participants
|
524 Participants
n=123 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=138 Participants
|
2 Participants
n=62 Participants
|
7 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=138 Participants
|
12 Participants
n=62 Participants
|
25 Participants
n=123 Participants
|
|
Geographic Region
Asian
|
242 Participants
n=138 Participants
|
244 Participants
n=62 Participants
|
486 Participants
n=123 Participants
|
|
Geographic Region
Non-Asian
|
291 Participants
n=138 Participants
|
292 Participants
n=62 Participants
|
583 Participants
n=123 Participants
|
|
Disease Status
Locally Advanced
|
60 Participants
n=138 Participants
|
66 Participants
n=62 Participants
|
126 Participants
n=123 Participants
|
|
Disease Status
Metastatic
|
473 Participants
n=138 Participants
|
470 Participants
n=62 Participants
|
943 Participants
n=123 Participants
|
|
Site of Origin
Gallbladder
|
115 Participants
n=138 Participants
|
118 Participants
n=62 Participants
|
233 Participants
n=123 Participants
|
|
Site of Origin
Intrahepatic
|
320 Participants
n=138 Participants
|
313 Participants
n=62 Participants
|
633 Participants
n=123 Participants
|
|
Site of Origin
Extrahepatic
|
98 Participants
n=138 Participants
|
105 Participants
n=62 Participants
|
203 Participants
n=123 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 38 monthsPopulation: All randomized participants
Overall survival was defined as the time from randomization to death due to any cause.
Outcome measures
| Measure |
Arm A: Pembrolizumab + Chemotherapy
n=533 Participants
Participants received pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with Gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression.
|
Arm B: Placebo + Chemotherapy
n=536 Participants
Participants received Placebo to Pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles.
|
|---|---|---|
|
Overall Survival (OS)
|
12.7 Months
Interval 11.5 to 13.6
|
10.9 Months
Interval 9.9 to 11.6
|
SECONDARY outcome
Timeframe: Up to approximately 26 monthsPopulation: All randomized participants
PFS was defined as the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by BICR per RECIST 1.1 was presented.
Outcome measures
| Measure |
Arm A: Pembrolizumab + Chemotherapy
n=533 Participants
Participants received pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with Gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression.
|
Arm B: Placebo + Chemotherapy
n=536 Participants
Participants received Placebo to Pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles.
|
|---|---|---|
|
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (BICR)
|
6.5 Months
Interval 5.7 to 6.9
|
5.6 Months
Interval 5.1 to 6.6
|
SECONDARY outcome
Timeframe: Up to approximately 26 monthsPopulation: All randomized participants
ORR was defined as the percentage of participants who have a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: a ≥30% decrease in the sum of diameters \[SOD\] of target lesions) as assessed by BICR per RECIST 1.1, which was adjusted for this study to allow a maximum of 10 target lesions in total and 5 per organ.
Outcome measures
| Measure |
Arm A: Pembrolizumab + Chemotherapy
n=533 Participants
Participants received pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with Gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression.
|
Arm B: Placebo + Chemotherapy
n=536 Participants
Participants received Placebo to Pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles.
|
|---|---|---|
|
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
|
28.7 Percentage of Participants
Interval 24.9 to 32.8
|
28.5 Percentage of Participants
Interval 24.8 to 32.6
|
SECONDARY outcome
Timeframe: Up to approximately 38 monthsPopulation: All randomized participants with CR or PR
For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until PD or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on BICR with confirmation. The DOR as assessed using RECIST 1.1 for all participants who experienced a confirmed CR or PR was presented.
Outcome measures
| Measure |
Arm A: Pembrolizumab + Chemotherapy
n=153 Participants
Participants received pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with Gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression.
|
Arm B: Placebo + Chemotherapy
n=153 Participants
Participants received Placebo to Pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles.
|
|---|---|---|
|
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
|
8.3 Months
Interval 6.9 to 10.2
|
6.8 Months
Interval 5.7 to 7.1
|
SECONDARY outcome
Timeframe: Up to approximately 65 monthsPopulation: All Participants as Treated (APaT) population, which consisted of all randomized participants who received at least 1 dose of study intervention
An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. Number of participants who experienced one or more AEs were reported.
Outcome measures
| Measure |
Arm A: Pembrolizumab + Chemotherapy
n=529 Participants
Participants received pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with Gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression.
|
Arm B: Placebo + Chemotherapy
n=534 Participants
Participants received Placebo to Pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles.
|
|---|---|---|
|
Number of Participants Who Experience One or More Adverse Events (AE)
|
524 Participants
|
532 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 63 monthsPopulation: All Participants as Treated (APaT) population, which consisted of all randomized participants who received at least 1 dose of study intervention.
An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurs during the course of the study. Number of participants who discontinued study intervention due to an AE were reported.
Outcome measures
| Measure |
Arm A: Pembrolizumab + Chemotherapy
n=529 Participants
Participants received pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with Gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression.
|
Arm B: Placebo + Chemotherapy
n=534 Participants
Participants received Placebo to Pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles.
|
|---|---|---|
|
Number of Participants Who Discontinued Study Intervention Due to an AE
|
140 Participants
|
125 Participants
|
Adverse Events
First Course: Arm A: Pembrolizumab + Chemotherapy
Serious events: 280 serious events
Other events: 513 other events
Deaths: 483 deaths
First Course: Arm B: Placebo + Chemotherapy
Serious events: 264 serious events
Other events: 522 other events
Deaths: 505 deaths
Second Course: Arm A: Pembrolizumab + Chemotherapy
Serious events: 0 serious events
Other events: 10 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
First Course: Arm A: Pembrolizumab + Chemotherapy
n=529 participants at risk
Participants received pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with Gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression.
|
First Course: Arm B: Placebo + Chemotherapy
n=534 participants at risk
Participants received Placebo to Pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles.
|
Second Course: Arm A: Pembrolizumab + Chemotherapy
n=10 participants at risk
Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200 mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with Gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.5%
13/529 • Number of events 13 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
1.9%
10/534 • Number of events 10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Blood and lymphatic system disorders
Coombs negative haemolytic anaemia
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.3%
7/529 • Number of events 8 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
1.5%
8/534 • Number of events 8 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.38%
2/529 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Blood and lymphatic system disorders
Microangiopathic haemolytic anaemia
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.38%
2/529 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.57%
3/529 • Number of events 3 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.57%
3/529 • Number of events 3 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Cardiac disorders
Angina pectoris
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Cardiac disorders
Atrial fibrillation
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Cardiac disorders
Cardiac arrest
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Cardiac disorders
Cardiac failure
|
1.1%
6/529 • Number of events 6 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.56%
3/534 • Number of events 3 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Cardiac disorders
Cardiomyopathy
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Cardiac disorders
Myocardial infarction
|
0.38%
2/529 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.75%
4/534 • Number of events 4 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Cardiac disorders
Myocarditis
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Cardiac disorders
Pericardial effusion
|
0.38%
2/529 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Cardiac disorders
Pericarditis
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.37%
2/534 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Endocrine disorders
Hyperthyroidism
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Endocrine disorders
Hypophysitis
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Endocrine disorders
Hypopituitarism
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Endocrine disorders
Hypothyroidism
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
6/529 • Number of events 7 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
1.3%
7/534 • Number of events 7 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Ascites
|
1.1%
6/529 • Number of events 7 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
2.4%
13/534 • Number of events 14 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Colitis
|
0.57%
3/529 • Number of events 3 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.37%
2/534 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Colonic fistula
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Constipation
|
0.38%
2/529 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.37%
2/534 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.57%
3/529 • Number of events 3 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
1.1%
6/534 • Number of events 6 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.38%
2/529 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.38%
2/529 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Fistula of small intestine
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Gastric stenosis
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.95%
5/529 • Number of events 5 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
0.19%
1/529 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Haematemesis
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Haemoperitoneum
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Ileus
|
0.76%
4/529 • Number of events 4 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.75%
4/534 • Number of events 6 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.38%
2/529 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.56%
3/534 • Number of events 3 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.38%
2/529 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Intestinal varices haemorrhage
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Jejunal perforation
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Malignant gastrointestinal obstruction
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.37%
2/534 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.37%
2/534 • Number of events 4 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Nausea
|
0.38%
2/529 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.37%
2/534 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.57%
3/529 • Number of events 3 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.38%
2/529 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.57%
3/529 • Number of events 3 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.37%
2/534 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Pancreatolithiasis
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Prepyloric stenosis
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.76%
4/529 • Number of events 5 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Subileus
|
0.38%
2/529 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.57%
3/529 • Number of events 3 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.56%
3/534 • Number of events 3 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
8/529 • Number of events 8 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.75%
4/534 • Number of events 4 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
General disorders
Asthenia
|
0.38%
2/529 • Number of events 3 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.56%
3/534 • Number of events 3 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
General disorders
Death
|
0.57%
3/529 • Number of events 3 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.94%
5/534 • Number of events 5 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
General disorders
Fatigue
|
0.38%
2/529 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.37%
2/534 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
General disorders
General physical health deterioration
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
General disorders
Hyperpyrexia
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
General disorders
Influenza like illness
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
General disorders
Malaise
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
General disorders
Oedema peripheral
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.37%
2/534 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
General disorders
Pain
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
General disorders
Peripheral swelling
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
General disorders
Puncture site haemorrhage
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
General disorders
Pyrexia
|
5.7%
30/529 • Number of events 34 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
2.2%
12/534 • Number of events 14 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Hepatobiliary disorders
Biliary obstruction
|
2.3%
12/529 • Number of events 14 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
3.0%
16/534 • Number of events 18 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Hepatobiliary disorders
Biloma
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Hepatobiliary disorders
Cholangitis
|
5.9%
31/529 • Number of events 39 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
4.5%
24/534 • Number of events 38 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Hepatobiliary disorders
Cholangitis acute
|
1.3%
7/529 • Number of events 8 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.56%
3/534 • Number of events 3 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.57%
3/529 • Number of events 3 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.56%
3/534 • Number of events 3 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Hepatobiliary disorders
Cholestasis
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Hepatobiliary disorders
Gallbladder rupture
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Hepatobiliary disorders
Hepatic displacement
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Hepatobiliary disorders
Hepatic haemorrhage
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Hepatobiliary disorders
Hepatic ischaemia
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.76%
4/529 • Number of events 4 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.75%
4/534 • Number of events 4 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.57%
3/529 • Number of events 3 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.94%
5/534 • Number of events 6 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Hepatobiliary disorders
Liver injury
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Hepatobiliary disorders
Portal hypertension
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Hepatobiliary disorders
Steatohepatitis
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Immune system disorders
Contrast media allergy
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Immune system disorders
Infusion related hypersensitivity reaction
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Abdominal abscess
|
0.57%
3/529 • Number of events 3 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Abdominal infection
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Abdominal wall abscess
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Arthritis bacterial
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Bacteraemia
|
1.5%
8/529 • Number of events 8 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Biliary sepsis
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.56%
3/534 • Number of events 3 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Biliary tract infection
|
3.2%
17/529 • Number of events 21 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
3.4%
18/534 • Number of events 26 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Burkholderia cepacia complex infection
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
COVID-19
|
1.3%
7/529 • Number of events 7 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
1.5%
8/534 • Number of events 8 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
COVID-19 pneumonia
|
1.1%
6/529 • Number of events 6 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.56%
3/534 • Number of events 3 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Cellulitis
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.56%
3/534 • Number of events 3 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Cholangitis infective
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.56%
3/534 • Number of events 4 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Device related infection
|
0.57%
3/529 • Number of events 3 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Diverticulitis
|
0.38%
2/529 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Encephalitis
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Enterobacter sepsis
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Enterocolitis infectious
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Febrile infection
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.37%
2/534 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Fungal sepsis
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Gastroenteritis
|
0.38%
2/529 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Hepatic infection
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Infection
|
0.76%
4/529 • Number of events 4 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Liver abscess
|
0.76%
4/529 • Number of events 4 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
2.1%
11/534 • Number of events 13 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.57%
3/529 • Number of events 3 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Mucosal infection
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Neutropenic infection
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Neutropenic sepsis
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Peritonitis
|
0.76%
4/529 • Number of events 4 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.56%
3/534 • Number of events 3 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Peritonitis bacterial
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Pleural infection
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Pneumococcal bacteraemia
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Pneumonia
|
1.5%
8/529 • Number of events 9 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
1.5%
8/534 • Number of events 10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Pneumonia acinetobacter
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Pneumonia aspiration
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.56%
3/534 • Number of events 3 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Pneumonia viral
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Postoperative abscess
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Pyelonephritis
|
0.57%
3/529 • Number of events 3 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Sepsis
|
2.5%
13/529 • Number of events 15 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
3.0%
16/534 • Number of events 17 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Septic embolus
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Septic shock
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.75%
4/534 • Number of events 4 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Skin infection
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Spontaneous bacterial peritonitis
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Systemic candida
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Urinary tract infection
|
1.9%
10/529 • Number of events 10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
1.1%
6/534 • Number of events 6 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Urosepsis
|
0.19%
1/529 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.37%
2/534 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Injury, poisoning and procedural complications
Fall
|
0.38%
2/529 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Injury, poisoning and procedural complications
Foreign body in gastrointestinal tract
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Injury, poisoning and procedural complications
Post procedural fever
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Injury, poisoning and procedural complications
Postoperative adhesion
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Injury, poisoning and procedural complications
Stoma site ulcer
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Injury, poisoning and procedural complications
Ureteric injury
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Investigations
Alanine aminotransferase increased
|
0.38%
2/529 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.75%
4/534 • Number of events 4 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Investigations
Aspartate aminotransferase increased
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Investigations
Blood bilirubin increased
|
0.95%
5/529 • Number of events 5 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.75%
4/534 • Number of events 4 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Investigations
Blood creatinine increased
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Investigations
Neutrophil count decreased
|
2.1%
11/529 • Number of events 13 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Investigations
Platelet count decreased
|
3.6%
19/529 • Number of events 19 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
1.9%
10/534 • Number of events 12 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Investigations
Transaminases increased
|
0.38%
2/529 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Investigations
Troponin increased
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Investigations
White blood cell count decreased
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.37%
2/534 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.76%
4/529 • Number of events 4 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.94%
5/534 • Number of events 5 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.38%
2/529 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.38%
2/529 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Metabolism and nutrition disorders
Food refusal
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.57%
3/529 • Number of events 3 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.38%
2/529 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.75%
4/534 • Number of events 4 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Musculoskeletal and connective tissue disorders
Chest wall haematoma
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.38%
2/529 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.37%
2/534 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of testis
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.56%
3/534 • Number of events 3 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis carcinomatosa
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.37%
2/534 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Nervous system disorders
Altered state of consciousness
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Nervous system disorders
Aphasia
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Nervous system disorders
Cerebral infarction
|
0.38%
2/529 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.56%
3/534 • Number of events 3 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Nervous system disorders
Cerebral venous sinus thrombosis
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.95%
5/529 • Number of events 5 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.75%
4/534 • Number of events 4 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Nervous system disorders
Headache
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.38%
2/529 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.37%
2/534 • Number of events 3 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Nervous system disorders
Lethargy
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Nervous system disorders
Myasthenia gravis
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Nervous system disorders
Radicular pain
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Nervous system disorders
Syncope
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Product Issues
Device dislocation
|
0.38%
2/529 • Number of events 3 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Product Issues
Device malfunction
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Product Issues
Device occlusion
|
0.38%
2/529 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Psychiatric disorders
Confusional state
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.37%
2/534 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Psychiatric disorders
Depressed mood
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.76%
4/529 • Number of events 5 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
1.9%
10/534 • Number of events 12 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Renal and urinary disorders
Renal failure
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.37%
2/534 • Number of events 3 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Renal and urinary disorders
Renal impairment
|
0.19%
1/529 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Renal and urinary disorders
Renal vein thrombosis
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.37%
2/534 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.38%
2/529 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.75%
4/534 • Number of events 4 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.19%
1/529 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.75%
4/534 • Number of events 4 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.3%
7/529 • Number of events 7 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.56%
3/534 • Number of events 3 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.38%
2/529 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.1%
11/529 • Number of events 11 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
1.5%
8/534 • Number of events 8 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.37%
2/534 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Skin and subcutaneous tissue disorders
Cutaneous vasculitis
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.38%
2/529 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Surgical and medical procedures
Euthanasia
|
0.38%
2/529 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Vascular disorders
Aortic aneurysm
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Vascular disorders
Deep vein thrombosis
|
0.38%
2/529 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Vascular disorders
Embolism
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.37%
2/534 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Vascular disorders
Haematoma
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Vascular disorders
Hypertension
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Vascular disorders
Hypovolaemic shock
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Vascular disorders
Inferior vena caval occlusion
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Vascular disorders
Shock
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Vascular disorders
Shock haemorrhagic
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Vascular disorders
Thrombosis
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Vascular disorders
Vena cava embolism
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
Other adverse events
| Measure |
First Course: Arm A: Pembrolizumab + Chemotherapy
n=529 participants at risk
Participants received pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with Gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression.
|
First Course: Arm B: Placebo + Chemotherapy
n=534 participants at risk
Participants received Placebo to Pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles.
|
Second Course: Arm A: Pembrolizumab + Chemotherapy
n=10 participants at risk
Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200 mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with Gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
59.5%
315/529 • Number of events 530 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
57.5%
307/534 • Number of events 488 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Endocrine disorders
Hypothyroidism
|
8.7%
46/529 • Number of events 47 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
2.6%
14/534 • Number of events 14 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Eye disorders
Blepharitis
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
10.0%
1/10 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Abdominal distension
|
7.0%
37/529 • Number of events 41 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
6.4%
34/534 • Number of events 43 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
10.0%
1/10 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.8%
89/529 • Number of events 124 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
21.9%
117/534 • Number of events 155 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
20.0%
2/10 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.6%
40/529 • Number of events 53 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
10.9%
58/534 • Number of events 74 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Ascites
|
5.7%
30/529 • Number of events 32 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
6.2%
33/534 • Number of events 34 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Constipation
|
35.0%
185/529 • Number of events 227 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
35.4%
189/534 • Number of events 234 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
30.0%
3/10 • Number of events 3 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Diarrhoea
|
19.3%
102/529 • Number of events 150 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
18.2%
97/534 • Number of events 155 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
10.0%
1/10 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
33/529 • Number of events 38 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
10.5%
56/534 • Number of events 65 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
20.0%
2/10 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Nausea
|
44.0%
233/529 • Number of events 419 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
46.4%
248/534 • Number of events 425 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
30.0%
3/10 • Number of events 4 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.37%
2/534 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
20.0%
2/10 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Stomatitis
|
4.9%
26/529 • Number of events 31 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
6.4%
34/534 • Number of events 37 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
10.0%
1/10 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Gastrointestinal disorders
Vomiting
|
22.7%
120/529 • Number of events 234 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
24.0%
128/534 • Number of events 276 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
General disorders
Asthenia
|
14.2%
75/529 • Number of events 134 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
17.4%
93/534 • Number of events 166 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
10.0%
1/10 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
General disorders
Fatigue
|
35.3%
187/529 • Number of events 284 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
32.2%
172/534 • Number of events 234 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
10.0%
1/10 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
General disorders
Influenza like illness
|
2.5%
13/529 • Number of events 13 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
1.3%
7/534 • Number of events 7 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
10.0%
1/10 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
General disorders
Malaise
|
6.8%
36/529 • Number of events 73 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
6.0%
32/534 • Number of events 60 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
General disorders
Mucosal inflammation
|
5.3%
28/529 • Number of events 34 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
4.3%
23/534 • Number of events 32 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
General disorders
Oedema peripheral
|
14.0%
74/529 • Number of events 88 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
16.1%
86/534 • Number of events 125 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
General disorders
Pyrexia
|
22.5%
119/529 • Number of events 239 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
18.0%
96/534 • Number of events 174 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
COVID-19
|
3.6%
19/529 • Number of events 20 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
2.8%
15/534 • Number of events 15 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
10.0%
1/10 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Infections and infestations
Urinary tract infection
|
5.5%
29/529 • Number of events 37 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
4.3%
23/534 • Number of events 26 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Investigations
Alanine aminotransferase increased
|
16.3%
86/529 • Number of events 152 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
20.8%
111/534 • Number of events 170 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Investigations
Aspartate aminotransferase increased
|
16.6%
88/529 • Number of events 175 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
18.5%
99/534 • Number of events 185 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
10.0%
1/10 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Investigations
Blood alkaline phosphatase increased
|
8.1%
43/529 • Number of events 60 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
9.7%
52/534 • Number of events 73 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Investigations
Blood bilirubin increased
|
9.1%
48/529 • Number of events 74 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
11.4%
61/534 • Number of events 81 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Investigations
Blood creatinine increased
|
10.6%
56/529 • Number of events 105 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
11.0%
59/534 • Number of events 105 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
10.0%
1/10 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Investigations
Gamma-glutamyltransferase increased
|
4.3%
23/529 • Number of events 30 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
5.4%
29/534 • Number of events 39 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Investigations
Lymphocyte count decreased
|
4.3%
23/529 • Number of events 49 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
5.4%
29/534 • Number of events 48 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Investigations
Neutrophil count decreased
|
62.0%
328/529 • Number of events 1405 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
61.2%
327/534 • Number of events 1298 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
20.0%
2/10 • Number of events 4 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Investigations
Platelet count decreased
|
39.3%
208/529 • Number of events 576 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
39.7%
212/534 • Number of events 604 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
10.0%
1/10 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Investigations
Weight decreased
|
9.6%
51/529 • Number of events 52 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
12.2%
65/534 • Number of events 77 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Investigations
White blood cell count decreased
|
26.7%
141/529 • Number of events 742 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
23.8%
127/534 • Number of events 653 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
26.8%
142/529 • Number of events 186 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
28.5%
152/534 • Number of events 207 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
10.0%
1/10 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
10.0%
1/10 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.8%
36/529 • Number of events 62 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
7.5%
40/534 • Number of events 51 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.6%
35/529 • Number of events 78 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
5.4%
29/534 • Number of events 35 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.2%
38/529 • Number of events 52 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
9.4%
50/534 • Number of events 68 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.3%
49/529 • Number of events 68 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
12.7%
68/534 • Number of events 96 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
14.9%
79/529 • Number of events 148 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
14.8%
79/534 • Number of events 139 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.6%
51/529 • Number of events 86 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
9.2%
49/534 • Number of events 59 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.4%
18/529 • Number of events 31 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
5.2%
28/534 • Number of events 49 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.4%
39/529 • Number of events 45 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
7.7%
41/534 • Number of events 52 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
10.0%
1/10 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.6%
56/529 • Number of events 70 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
13.5%
72/534 • Number of events 77 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
10.0%
1/10 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
28/529 • Number of events 37 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
5.8%
31/534 • Number of events 35 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
28/529 • Number of events 35 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
4.3%
23/534 • Number of events 25 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Nervous system disorders
Dizziness
|
6.0%
32/529 • Number of events 44 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
9.4%
50/534 • Number of events 55 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
10.0%
1/10 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Nervous system disorders
Dysgeusia
|
5.9%
31/529 • Number of events 34 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
6.0%
32/534 • Number of events 34 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Nervous system disorders
Headache
|
10.0%
53/529 • Number of events 80 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
8.6%
46/534 • Number of events 54 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Nervous system disorders
Neuropathy peripheral
|
4.0%
21/529 • Number of events 23 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
5.6%
30/534 • Number of events 32 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.9%
31/529 • Number of events 33 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
5.2%
28/534 • Number of events 29 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Psychiatric disorders
Insomnia
|
8.1%
43/529 • Number of events 48 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
7.7%
41/534 • Number of events 45 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.19%
1/529 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.94%
5/534 • Number of events 5 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
10.0%
1/10 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.2%
38/529 • Number of events 44 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
7.3%
39/534 • Number of events 45 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.6%
51/529 • Number of events 59 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
9.6%
51/534 • Number of events 56 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.0%
16/529 • Number of events 18 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.94%
5/534 • Number of events 5 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
10.0%
1/10 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.1%
11/529 • Number of events 11 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.94%
5/534 • Number of events 6 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
10.0%
1/10 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.1%
6/529 • Number of events 6 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
1.3%
7/534 • Number of events 7 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
10.0%
1/10 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.4%
55/529 • Number of events 58 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
12.7%
68/534 • Number of events 71 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.7%
25/529 • Number of events 29 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
3.4%
18/534 • Number of events 22 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
10.0%
1/10 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
10.0%
1/10 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.38%
2/529 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.75%
4/534 • Number of events 4 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
10.0%
1/10 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.7%
78/529 • Number of events 107 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
9.6%
51/534 • Number of events 60 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
10.0%
1/10 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.8%
89/529 • Number of events 114 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
9.2%
49/534 • Number of events 64 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
20.0%
2/10 • Number of events 2 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/529 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/534 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
10.0%
1/10 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Vascular disorders
Hypertension
|
6.4%
34/529 • Number of events 40 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
6.9%
37/534 • Number of events 61 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.00%
0/10 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
|
Vascular disorders
Vasculitis
|
0.38%
2/529 • Number of events 3 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
0.19%
1/534 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
10.0%
1/10 • Number of events 1 • Up to approximately 65 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study intervention. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study intervention were excluded. ACM \& AEs were reported separately for second course treatment for Arm A as per protocol.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER