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)-China Extension Study (NCT NCT04924062)
NCT ID: NCT04924062
Last Updated: 2026-04-15
Results Overview
Overall survival was defined as the time from randomization to death due to any cause. Per protocol the final reported outcome for OS did not include any sensitivity or supportive analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
158 participants
Primary outcome timeframe
Up to approximately 29 months
Results posted on
2026-04-15
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.
158 Chinese participants were randomized (global study \[NCT04003636; n=112\] or to the extension portion \[n=46\]).
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 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.
|
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
|
75
|
83
|
|
Overall Study
Treated
|
74
|
82
|
|
Overall Study
Participants Who Received Second Course of Pembrolizumab
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
75
|
83
|
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 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.
|
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
|
65
|
77
|
|
Overall Study
Sponsor Decision
|
10
|
6
|
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)-China Extension Study
Baseline characteristics by cohort
| Measure |
Arm A: Pembrolizumab + Chemotherapy
n=75 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 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.
|
Arm B: Placebo + Chemotherapy
n=83 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=158 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.5 Years
STANDARD_DEVIATION 8.3 • n=193 Participants
|
58.6 Years
STANDARD_DEVIATION 9.5 • n=193 Participants
|
59.0 Years
STANDARD_DEVIATION 8.9 • n=386 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=193 Participants
|
36 Participants
n=193 Participants
|
75 Participants
n=386 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=193 Participants
|
47 Participants
n=193 Participants
|
83 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
75 Participants
n=193 Participants
|
83 Participants
n=193 Participants
|
158 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Asian
|
75 Participants
n=193 Participants
|
83 Participants
n=193 Participants
|
158 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Geographic Region
Asia
|
75 Participants
n=193 Participants
|
83 Participants
n=193 Participants
|
158 Participants
n=386 Participants
|
|
Disease Status
Locally Advanced
|
12 Participants
n=193 Participants
|
14 Participants
n=193 Participants
|
26 Participants
n=386 Participants
|
|
Disease Status
Metastatic
|
63 Participants
n=193 Participants
|
69 Participants
n=193 Participants
|
132 Participants
n=386 Participants
|
|
Site of Origin
Gallbladder
|
19 Participants
n=193 Participants
|
12 Participants
n=193 Participants
|
31 Participants
n=386 Participants
|
|
Site of Origin
Intrahepatic
|
45 Participants
n=193 Participants
|
60 Participants
n=193 Participants
|
105 Participants
n=386 Participants
|
|
Site of Origin
Extrahepatic
|
11 Participants
n=193 Participants
|
11 Participants
n=193 Participants
|
22 Participants
n=386 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 29 monthsPopulation: All randomized participants
Overall survival was defined as the time from randomization to death due to any cause. Per protocol the final reported outcome for OS did not include any sensitivity or supportive analysis.
Outcome measures
| Measure |
Arm A: Pembrolizumab + Chemotherapy
n=75 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 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.
|
Arm B: Placebo + Chemotherapy
n=83 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)
|
14.1 Months
Interval 10.4 to 17.7
|
9.9 Months
Interval 8.6 to 13.0
|
SECONDARY outcome
Timeframe: Up to approximately 29 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=75 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 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.
|
Arm B: Placebo + Chemotherapy
n=83 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 BICR
|
5.6 Months
Interval 3.2 to 7.4
|
5.7 Months
Interval 4.4 to 6.9
|
SECONDARY outcome
Timeframe: Up to approximately 29 monthsPopulation: All randomized participants
ORR was defined as the percentage of participants who had 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=75 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 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.
|
Arm B: Placebo + Chemotherapy
n=83 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 RECIST 1.1 as Assessed by BICR
|
36.0 Percentage of participants
Interval 25.2 to 47.9
|
28.9 Percentage of participants
Interval 19.5 to 39.9
|
SECONDARY outcome
Timeframe: Up to approximately 29 monthsPopulation: All responders (participants that achieved complete or partial response)
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=27 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 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.
|
Arm B: Placebo + Chemotherapy
n=24 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
|
10.2 Months
Interval 5.4 to
NA = Upper limit of DOR not reached due to insufficient number of participants with events in the study.
|
5.7 Months
Interval 4.2 to 14.0
|
SECONDARY outcome
Timeframe: Up to approximately 29 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 was reported.
Outcome measures
| Measure |
Arm A: Pembrolizumab + Chemotherapy
n=74 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 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.
|
Arm B: Placebo + Chemotherapy
n=82 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 Experienced One or More Adverse Events (AEs)
|
73 Participants
|
82 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 29 monthsPopulation: 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 occurred during the course of the study. Number of participants who discontinued study intervention (includes any study medication given during the study) due to an AE were reported.
Outcome measures
| Measure |
Arm A: Pembrolizumab + Chemotherapy
n=74 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 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.
|
Arm B: Placebo + Chemotherapy
n=82 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
|
18 Participants
|
14 Participants
|
Adverse Events
First Course: Arm A: Pembrolizumab + Chemotherapy
Serious events: 29 serious events
Other events: 73 other events
Deaths: 65 deaths
First Course: Arm B: Placebo + Chemotherapy
Serious events: 29 serious events
Other events: 82 other events
Deaths: 77 deaths
Second Course: Arm A: Pembrolizumab + Chemotherapy
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
First Course: Arm A: Pembrolizumab + Chemotherapy
n=74 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.
|
First Course: Arm B: Placebo + Chemotherapy
n=82 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=1 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
|
6.8%
5/74 • Number of events 5 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
3.7%
3/82 • Number of events 3 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/74 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
1.2%
1/82 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
2.7%
2/74 • Number of events 2 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
1.2%
1/82 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Cardiac disorders
Myocardial infarction
|
1.4%
1/74 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
1.2%
1/82 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Cardiac disorders
Myocarditis
|
1.4%
1/74 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
2.4%
2/82 • Number of events 2 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Endocrine disorders
Hypopituitarism
|
1.4%
1/74 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/82 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/74 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
1.2%
1/82 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Gastrointestinal disorders
Ascites
|
1.4%
1/74 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/82 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Gastrointestinal disorders
Ileus
|
1.4%
1/74 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/82 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
1.4%
1/74 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/82 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.4%
1/74 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
1.2%
1/82 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
1/74 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/82 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
General disorders
Death
|
1.4%
1/74 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
2.4%
2/82 • Number of events 2 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
General disorders
Multiple organ dysfunction syndrome
|
1.4%
1/74 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/82 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
General disorders
Pyrexia
|
1.4%
1/74 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
1.2%
1/82 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/74 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
1.2%
1/82 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Hepatobiliary disorders
Biliary obstruction
|
1.4%
1/74 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
2.4%
2/82 • Number of events 2 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Hepatobiliary disorders
Hepatic cyst
|
1.4%
1/74 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/82 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.4%
1/74 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/82 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
1.4%
1/74 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
6.1%
5/82 • Number of events 5 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Hepatobiliary disorders
Liver injury
|
1.4%
1/74 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/82 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Infections and infestations
Bacteraemia
|
1.4%
1/74 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/82 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Infections and infestations
Biliary tract infection
|
5.4%
4/74 • Number of events 6 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
4.9%
4/82 • Number of events 5 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Infections and infestations
Enterocolitis infectious
|
1.4%
1/74 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/82 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Infections and infestations
Febrile infection
|
2.7%
2/74 • Number of events 2 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
1.2%
1/82 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Infections and infestations
Gastroenteritis
|
1.4%
1/74 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/82 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/74 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
1.2%
1/82 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Infections and infestations
Peritonitis
|
1.4%
1/74 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/82 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Infections and infestations
Pneumonia
|
1.4%
1/74 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
1.2%
1/82 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Infections and infestations
Sepsis
|
1.4%
1/74 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/82 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Infections and infestations
Urinary tract infection
|
1.4%
1/74 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
1.2%
1/82 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Investigations
Alanine aminotransferase increased
|
1.4%
1/74 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
2.4%
2/82 • Number of events 2 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/74 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
1.2%
1/82 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Investigations
Myocardial necrosis marker increased
|
0.00%
0/74 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
1.2%
1/82 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Investigations
Neutrophil count decreased
|
6.8%
5/74 • Number of events 6 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
2.4%
2/82 • Number of events 2 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/74 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
1.2%
1/82 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Investigations
Platelet count decreased
|
12.2%
9/74 • Number of events 9 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
8.5%
7/82 • Number of events 11 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Investigations
White blood cell count decreased
|
4.1%
3/74 • Number of events 3 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
3.7%
3/82 • Number of events 3 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/74 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
1.2%
1/82 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
1.4%
1/74 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/82 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/74 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
1.2%
1/82 • Number of events 2 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
2.7%
2/74 • Number of events 2 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/82 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/74 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
1.2%
1/82 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Nervous system disorders
Haemorrhage intracranial
|
1.4%
1/74 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/82 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Nervous system disorders
Myasthenia gravis
|
1.4%
1/74 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/82 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.4%
1/74 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/82 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/74 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
1.2%
1/82 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.4%
1/74 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
1.2%
1/82 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/74 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
1.2%
1/82 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/74 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
1.2%
1/82 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Vascular disorders
Embolism
|
1.4%
1/74 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/82 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Vascular disorders
Hypertension
|
0.00%
0/74 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
2.4%
2/82 • Number of events 2 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Vascular disorders
Thrombosis
|
1.4%
1/74 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/82 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
Other adverse events
| Measure |
First Course: Arm A: Pembrolizumab + Chemotherapy
n=74 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.
|
First Course: Arm B: Placebo + Chemotherapy
n=82 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=1 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
|
79.7%
59/74 • Number of events 106 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
79.3%
65/82 • Number of events 100 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Endocrine disorders
Hyperthyroidism
|
6.8%
5/74 • Number of events 5 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
2.4%
2/82 • Number of events 2 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Endocrine disorders
Hypothyroidism
|
16.2%
12/74 • Number of events 14 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
3.7%
3/82 • Number of events 3 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Gastrointestinal disorders
Abdominal distension
|
9.5%
7/74 • Number of events 10 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
9.8%
8/82 • Number of events 10 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.8%
5/74 • Number of events 10 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
7.3%
6/82 • Number of events 7 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.1%
6/74 • Number of events 9 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
13.4%
11/82 • Number of events 22 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/74 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
8.5%
7/82 • Number of events 7 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Gastrointestinal disorders
Constipation
|
20.3%
15/74 • Number of events 26 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
24.4%
20/82 • Number of events 30 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.2%
12/74 • Number of events 16 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
7.3%
6/82 • Number of events 8 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Gastrointestinal disorders
Nausea
|
51.4%
38/74 • Number of events 97 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
42.7%
35/82 • Number of events 88 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Gastrointestinal disorders
Vomiting
|
41.9%
31/74 • Number of events 82 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
45.1%
37/82 • Number of events 88 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
General disorders
Asthenia
|
18.9%
14/74 • Number of events 40 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
13.4%
11/82 • Number of events 25 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
General disorders
Chest discomfort
|
6.8%
5/74 • Number of events 6 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
6.1%
5/82 • Number of events 6 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
General disorders
Fatigue
|
6.8%
5/74 • Number of events 5 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
8.5%
7/82 • Number of events 7 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
General disorders
Malaise
|
16.2%
12/74 • Number of events 29 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
13.4%
11/82 • Number of events 20 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
General disorders
Oedema peripheral
|
6.8%
5/74 • Number of events 5 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
6.1%
5/82 • Number of events 7 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
General disorders
Pyrexia
|
14.9%
11/74 • Number of events 16 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
12.2%
10/82 • Number of events 17 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
6.8%
5/74 • Number of events 16 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
7.3%
6/82 • Number of events 11 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Hepatobiliary disorders
Hepatic pain
|
5.4%
4/74 • Number of events 5 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
2.4%
2/82 • Number of events 2 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Infections and infestations
COVID-19
|
6.8%
5/74 • Number of events 5 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
3.7%
3/82 • Number of events 3 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.8%
5/74 • Number of events 5 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
8.5%
7/82 • Number of events 8 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Investigations
Alanine aminotransferase increased
|
21.6%
16/74 • Number of events 34 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
34.1%
28/82 • Number of events 45 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Investigations
Aspartate aminotransferase increased
|
25.7%
19/74 • Number of events 41 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
36.6%
30/82 • Number of events 57 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
100.0%
1/1 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Investigations
Bile acids increased
|
5.4%
4/74 • Number of events 6 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
7.3%
6/82 • Number of events 10 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Investigations
Blood alkaline phosphatase increased
|
16.2%
12/74 • Number of events 12 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
9.8%
8/82 • Number of events 10 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Investigations
Blood bilirubin increased
|
14.9%
11/74 • Number of events 14 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
18.3%
15/82 • Number of events 25 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Investigations
Blood creatinine increased
|
4.1%
3/74 • Number of events 10 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
11.0%
9/82 • Number of events 21 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Investigations
Blood lactate dehydrogenase increased
|
8.1%
6/74 • Number of events 11 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
7.3%
6/82 • Number of events 21 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Investigations
Gamma-glutamyltransferase increased
|
10.8%
8/74 • Number of events 13 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
14.6%
12/82 • Number of events 18 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Investigations
Lymphocyte count decreased
|
17.6%
13/74 • Number of events 35 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
15.9%
13/82 • Number of events 26 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Investigations
Neutrophil count decreased
|
74.3%
55/74 • Number of events 329 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
70.7%
58/82 • Number of events 321 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Investigations
Neutrophil count increased
|
5.4%
4/74 • Number of events 8 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
1.2%
1/82 • Number of events 2 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Investigations
Platelet count decreased
|
63.5%
47/74 • Number of events 213 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
56.1%
46/82 • Number of events 154 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Investigations
Weight decreased
|
13.5%
10/74 • Number of events 10 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
17.1%
14/82 • Number of events 19 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Investigations
Weight increased
|
5.4%
4/74 • Number of events 4 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
7.3%
6/82 • Number of events 6 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Investigations
White blood cell count decreased
|
78.4%
58/74 • Number of events 379 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
75.6%
62/82 • Number of events 327 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
27.0%
20/74 • Number of events 47 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
34.1%
28/82 • Number of events 56 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
6.8%
5/74 • Number of events 5 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
6.1%
5/82 • Number of events 5 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.1%
6/74 • Number of events 13 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
9.8%
8/82 • Number of events 11 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
12.2%
9/74 • Number of events 41 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
13.4%
11/82 • Number of events 23 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
13.5%
10/74 • Number of events 13 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
19.5%
16/82 • Number of events 27 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.4%
1/74 • Number of events 3 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
7.3%
6/82 • Number of events 8 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
2.7%
2/74 • Number of events 5 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
12.2%
10/82 • Number of events 16 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.9%
11/74 • Number of events 16 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
15.9%
13/82 • Number of events 18 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
8.1%
6/74 • Number of events 13 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
14.6%
12/82 • Number of events 28 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.1%
6/74 • Number of events 17 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
18.3%
15/82 • Number of events 21 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
4.1%
3/74 • Number of events 3 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
7.3%
6/82 • Number of events 13 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.7%
2/74 • Number of events 2 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
6.1%
5/82 • Number of events 6 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Nervous system disorders
Dizziness
|
4.1%
3/74 • Number of events 3 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
9.8%
8/82 • Number of events 9 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Nervous system disorders
Headache
|
6.8%
5/74 • Number of events 7 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
3.7%
3/82 • Number of events 3 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Psychiatric disorders
Insomnia
|
6.8%
5/74 • Number of events 5 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
6.1%
5/82 • Number of events 5 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Renal and urinary disorders
Renal impairment
|
5.4%
4/74 • Number of events 10 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
2.4%
2/82 • Number of events 2 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.4%
4/74 • Number of events 6 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
3.7%
3/82 • Number of events 3 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.2%
12/74 • Number of events 12 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
13.4%
11/82 • Number of events 11 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.4%
4/74 • Number of events 5 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
3.7%
3/82 • Number of events 3 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.3%
15/74 • Number of events 19 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
9.8%
8/82 • Number of events 15 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
5.4%
4/74 • Number of events 4 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
2.4%
2/82 • Number of events 2 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Vascular disorders
Hypertension
|
1.4%
1/74 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
6.1%
5/82 • Number of events 11 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
|
Vascular disorders
Thrombosis
|
5.4%
4/74 • Number of events 4 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/82 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
0.00%
0/1 • Up to approximately 56 months
All-Cause Mortality (ACM) included all randomized participants. AEs included all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer under study wasn't considered an AE unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study treatment were excluded as AEs. Per protocol, ACM \& AEs were reported separately for second course treatment for Arm A.
|
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 agreed to submit all manuscripts or abstracts to the Sponsor before submission. This allowed the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER