Trial Outcomes & Findings for Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008/KEYSTEP-008). (NCT NCT04895722)
NCT ID: NCT04895722
Last Updated: 2026-07-02
Results Overview
ORR was defined as the percentage of participants who have a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR as assessed by BICR is presented.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
302 participants
Primary outcome timeframe
Up to approximately 46 months
Results posted on
2026-07-02
Participant Flow
Per protocol, response/progression or adverse events (AEs) that occurred during the second course of pembrolizumab were not included in efficacy or safety outcome measures.
Participant milestones
| Measure |
Cohort A - Pembrolizumab/Quavonlimab
Participants in Cohort A received co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) every 6 weeks (Q6W) for up to approximately 2 years.
At the investigator's discretion, eligible participants randomized to the pembrolizumab/quavonlimab arm who completed the first course of pembrolizumab/quavonlimab or who had stopped pembrolizumab/quavonlimab due to confirmed complete response (CR) initiated a second course of pembrolizumab/quavonlimab (400 mg/25 mg) Q6W for up to approximately 1 additional year.
|
Cohort A - Pembrolizumab
Participants in Cohort A received pembrolizumab 400 mg intravenously (IV) Q6W for up to approximately 2 years.
At the investigator's discretion, eligible participants randomized to the pembrolizumab arm who completed the first course of pembrolizumab or who had stopped pembrolizumab due to confirmed CR initiated a second course of pembrolizumab 400 mg Q6W for up to approximately 1 additional year.
|
Cohort B - Pembrolizumab/Quavonlimab
Participants received co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) Q6W for up to approximately 2 years.
|
Cohort B - Pembrolizumab Plus MK-4830
Participants received pembrolizumab 200 mg plus MK-4830 800 mg Q3W for up to approximately 2 years.
|
Cohort B - Pembrolizumab/Favezelimab
Participants received co-formulated pembrolizumab/favezelimab (200 mg/800 mg) every 3 weeks (Q3W) for up to approximately 2 years.
|
Cohort B - Pembrolizumab/Vibostolimab
Participants received co-formulated pembrolizumab/vibostolimab (200 mg/200 mg) Q3W for up to approximately 2 years.
|
Cohort B - Pembrolizumab
Participants in Cohort B received pembrolizumab 400 mg IV Q6W for up to approximately 2 years.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
60
|
61
|
39
|
20
|
40
|
41
|
41
|
|
Overall Study
Treated
|
60
|
60
|
39
|
20
|
40
|
41
|
41
|
|
Overall Study
Received Second Course Treatment
|
1
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
60
|
61
|
39
|
20
|
40
|
41
|
41
|
Reasons for withdrawal
| Measure |
Cohort A - Pembrolizumab/Quavonlimab
Participants in Cohort A received co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) every 6 weeks (Q6W) for up to approximately 2 years.
At the investigator's discretion, eligible participants randomized to the pembrolizumab/quavonlimab arm who completed the first course of pembrolizumab/quavonlimab or who had stopped pembrolizumab/quavonlimab due to confirmed complete response (CR) initiated a second course of pembrolizumab/quavonlimab (400 mg/25 mg) Q6W for up to approximately 1 additional year.
|
Cohort A - Pembrolizumab
Participants in Cohort A received pembrolizumab 400 mg intravenously (IV) Q6W for up to approximately 2 years.
At the investigator's discretion, eligible participants randomized to the pembrolizumab arm who completed the first course of pembrolizumab or who had stopped pembrolizumab due to confirmed CR initiated a second course of pembrolizumab 400 mg Q6W for up to approximately 1 additional year.
|
Cohort B - Pembrolizumab/Quavonlimab
Participants received co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) Q6W for up to approximately 2 years.
|
Cohort B - Pembrolizumab Plus MK-4830
Participants received pembrolizumab 200 mg plus MK-4830 800 mg Q3W for up to approximately 2 years.
|
Cohort B - Pembrolizumab/Favezelimab
Participants received co-formulated pembrolizumab/favezelimab (200 mg/800 mg) every 3 weeks (Q3W) for up to approximately 2 years.
|
Cohort B - Pembrolizumab/Vibostolimab
Participants received co-formulated pembrolizumab/vibostolimab (200 mg/200 mg) Q3W for up to approximately 2 years.
|
Cohort B - Pembrolizumab
Participants in Cohort B received pembrolizumab 400 mg IV Q6W for up to approximately 2 years.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
22
|
30
|
11
|
6
|
11
|
9
|
11
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
|
Overall Study
Sponsor Decision
|
0
|
0
|
0
|
0
|
3
|
4
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
2
|
1
|
0
|
0
|
|
Overall Study
Participant Ongoing in Trial
|
37
|
31
|
27
|
12
|
24
|
26
|
30
|
Baseline Characteristics
Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008/KEYSTEP-008).
Baseline characteristics by cohort
| Measure |
Cohort A - Pembrolizumab/Quavonlimab
n=60 Participants
Participants in Cohort A received co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) every 6 weeks (Q6W) for up to approximately 2 years.
At the investigator's discretion, eligible participants randomized to the pembrolizumab/quavonlimab arm who completed the first course of pembrolizumab/quavonlimab or who had stopped pembrolizumab/quavonlimab due to confirmed complete response (CR) initiated a second course of pembrolizumab/quavonlimab (400 mg/25 mg) Q6W for up to approximately 1 additional year.
|
Cohort A - Pembrolizumab
n=61 Participants
Participants in Cohort A received pembrolizumab 400 mg intravenously (IV) Q6W for up to approximately 2 years.
At the investigator's discretion, eligible participants randomized to the pembrolizumab arm who completed the first course of pembrolizumab or who had stopped pembrolizumab due to confirmed CR initiated a second course of pembrolizumab 400 mg Q6W for up to approximately 1 additional year.
|
Cohort B - Pembrolizumab/Quavonlimab
n=39 Participants
Participants received co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) Q6W for up to approximately 2 years.
|
Cohort B - Pembrolizumab Plus MK-4830
n=20 Participants
Participants received pembrolizumab 200 mg plus MK-4830 800 mg Q3W for up to approximately 2 years.
|
Cohort B - Pembrolizumab/Favezelimab
n=40 Participants
Participants received co-formulated pembrolizumab/favezelimab (200 mg/800 mg) every 3 weeks (Q3W) for up to approximately 2 years.
|
Cohort B - Pembrolizumab/Vibostolimab
n=41 Participants
Participants received co-formulated pembrolizumab/vibostolimab (200 mg/200 mg) Q3W for up to approximately 2 years.
|
Cohort B - Pembrolizumab
n=41 Participants
Participants in Cohort B received pembrolizumab 400 mg IV Q6W for up to approximately 2 years.
|
Total
n=302 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
59.6 Years
STANDARD_DEVIATION 11.9 • n=20 Participants
|
58.4 Years
STANDARD_DEVIATION 12.9 • n=20 Participants
|
60.1 Years
STANDARD_DEVIATION 13.9 • n=40 Participants
|
64.5 Years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
57.3 Years
STANDARD_DEVIATION 16.5 • n=9 Participants
|
58.1 Years
STANDARD_DEVIATION 15.5 • n=6 Participants
|
64.2 Years
STANDARD_DEVIATION 14.3 • n=6 Participants
|
59.9 Years
STANDARD_DEVIATION 14.0 • n=6 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=20 Participants
|
25 Participants
n=20 Participants
|
17 Participants
n=40 Participants
|
10 Participants
n=5 Participants
|
20 Participants
n=9 Participants
|
22 Participants
n=6 Participants
|
18 Participants
n=6 Participants
|
133 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=20 Participants
|
36 Participants
n=20 Participants
|
22 Participants
n=40 Participants
|
10 Participants
n=5 Participants
|
20 Participants
n=9 Participants
|
19 Participants
n=6 Participants
|
23 Participants
n=6 Participants
|
169 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
10 Participants
n=6 Participants
|
41 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
56 Participants
n=20 Participants
|
52 Participants
n=20 Participants
|
32 Participants
n=40 Participants
|
17 Participants
n=5 Participants
|
32 Participants
n=9 Participants
|
31 Participants
n=6 Participants
|
28 Participants
n=6 Participants
|
248 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
13 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
7 Participants
n=6 Participants
|
20 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
7 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
44 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=20 Participants
|
44 Participants
n=20 Participants
|
29 Participants
n=40 Participants
|
13 Participants
n=5 Participants
|
35 Participants
n=9 Participants
|
33 Participants
n=6 Participants
|
24 Participants
n=6 Participants
|
223 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
13 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
RAS Mutation Status
RAS Mutant
|
25 Participants
n=20 Participants
|
25 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
8 Participants
n=5 Participants
|
15 Participants
n=9 Participants
|
15 Participants
n=6 Participants
|
15 Participants
n=6 Participants
|
117 Participants
n=6 Participants
|
|
RAS Mutation Status
RAS Wildtype
|
35 Participants
n=20 Participants
|
36 Participants
n=20 Participants
|
25 Participants
n=40 Participants
|
12 Participants
n=5 Participants
|
25 Participants
n=9 Participants
|
26 Participants
n=6 Participants
|
26 Participants
n=6 Participants
|
185 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 46 monthsPopulation: All randomized participants were analyzed.
ORR was defined as the percentage of participants who have a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR as assessed by BICR is presented.
Outcome measures
| Measure |
Cohort A - Pembrolizumab/Quavonlimab
n=60 Participants
Participants in Cohort A received co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) every 6 weeks (Q6W) for up to approximately 2 years.
At the investigator's discretion, eligible participants randomized to the pembrolizumab/quavonlimab arm who completed the first course of pembrolizumab/quavonlimab or who had stopped pembrolizumab/quavonlimab due to confirmed complete response (CR) initiated a second course of pembrolizumab/quavonlimab (400 mg/25 mg) Q6W for up to approximately 1 additional year.
|
Cohort A - Pembrolizumab
n=61 Participants
Participants in Cohort A received pembrolizumab 400 mg intravenously (IV) Q6W for up to approximately 2 years.
At the investigator's discretion, eligible participants randomized to the pembrolizumab arm who completed the first course of pembrolizumab or who had stopped pembrolizumab due to confirmed CR initiated a second course of pembrolizumab 400 mg Q6W for up to approximately 1 additional year.
|
Cohort B - Pembrolizumab/Quavonlimab
n=39 Participants
Participants received co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) Q6W for up to approximately 2 years.
|
Cohort B - Pembrolizumab Plus MK-4830
n=20 Participants
Participants received pembrolizumab 200 mg plus MK-4830 800 mg Q3W for up to approximately 2 years.
|
Cohort B - Pembrolizumab/Favezelimab
n=40 Participants
Participants received co-formulated pembrolizumab/favezelimab (200 mg/800 mg) every 3 weeks (Q3W) for up to approximately 2 years.
|
Cohort B - Pembrolizumab/Vibostolimab
n=41 Participants
Participants received co-formulated pembrolizumab/vibostolimab (200 mg/200 mg) Q3W for up to approximately 2 years.
|
Cohort B - Pembrolizumab
n=41 Participants
Participants in Cohort B received pembrolizumab 400 mg IV Q6W for up to approximately 2 years.
|
|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
|
45.0 Percentage of Participants
Interval 32.1 to 58.4
|
29.5 Percentage of Participants
Interval 18.5 to 42.6
|
46.2 Percentage of Participants
Interval 30.1 to 62.8
|
65.0 Percentage of Participants
Interval 40.8 to 84.6
|
37.5 Percentage of Participants
Interval 22.7 to 54.2
|
48.8 Percentage of Participants
Interval 32.9 to 64.9
|
41.5 Percentage of Participants
Interval 26.3 to 57.9
|
SECONDARY outcome
Timeframe: Up to approximately 46 monthsPopulation: All randomized participants who experienced CR or PR as assessed by BICR were analyzed.
DOR was defined as the time from the first documented evidence of a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 until Progressive Disease (PD) or death due to any cause, whichever occurs first, in participants demonstrating a CR or PR. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. DOR as assessed by BICR is presented.
Outcome measures
| Measure |
Cohort A - Pembrolizumab/Quavonlimab
n=27 Participants
Participants in Cohort A received co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) every 6 weeks (Q6W) for up to approximately 2 years.
At the investigator's discretion, eligible participants randomized to the pembrolizumab/quavonlimab arm who completed the first course of pembrolizumab/quavonlimab or who had stopped pembrolizumab/quavonlimab due to confirmed complete response (CR) initiated a second course of pembrolizumab/quavonlimab (400 mg/25 mg) Q6W for up to approximately 1 additional year.
|
Cohort A - Pembrolizumab
n=18 Participants
Participants in Cohort A received pembrolizumab 400 mg intravenously (IV) Q6W for up to approximately 2 years.
At the investigator's discretion, eligible participants randomized to the pembrolizumab arm who completed the first course of pembrolizumab or who had stopped pembrolizumab due to confirmed CR initiated a second course of pembrolizumab 400 mg Q6W for up to approximately 1 additional year.
|
Cohort B - Pembrolizumab/Quavonlimab
n=18 Participants
Participants received co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) Q6W for up to approximately 2 years.
|
Cohort B - Pembrolizumab Plus MK-4830
n=13 Participants
Participants received pembrolizumab 200 mg plus MK-4830 800 mg Q3W for up to approximately 2 years.
|
Cohort B - Pembrolizumab/Favezelimab
n=15 Participants
Participants received co-formulated pembrolizumab/favezelimab (200 mg/800 mg) every 3 weeks (Q3W) for up to approximately 2 years.
|
Cohort B - Pembrolizumab/Vibostolimab
n=20 Participants
Participants received co-formulated pembrolizumab/vibostolimab (200 mg/200 mg) Q3W for up to approximately 2 years.
|
Cohort B - Pembrolizumab
n=17 Participants
Participants in Cohort B received pembrolizumab 400 mg IV Q6W for up to approximately 2 years.
|
|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
|
NA Months
NA = Median, upper, and lower limit as appropriate not reached at time of data cut-off due to insufficient number of responding participants with relapse.
|
NA Months
Interval 33.7 to
NA = Median and upper limit as appropriate not reached at time of data cut-off due to insufficient number of responding participants with relapse.
|
NA Months
NA = Median, upper, and lower limit as appropriate not reached at time of data cut-off due to insufficient number of responding participants with relapse.
|
NA Months
Interval 20.8 to
NA = Median and upper limit as appropriate not reached at time of data cut-off due to insufficient number of responding participants with relapse.
|
NA Months
NA = Median, upper, and lower limit as appropriate not reached at time of data cut-off due to insufficient number of responding participants with relapse.
|
NA Months
NA = Median, upper, and lower limit as appropriate not reached at time of data cut-off due to insufficient number of responding participants with relapse.
|
NA Months
NA = Median, upper, and lower limit as appropriate not reached at time of data cut-off due to insufficient number of responding participants with relapse.
|
SECONDARY outcome
Timeframe: Up to approximately 46 monthsPopulation: All randomized participants were analyzed.
PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 or death from any cause, whichever occurs first. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by BICR is presented.
Outcome measures
| Measure |
Cohort A - Pembrolizumab/Quavonlimab
n=60 Participants
Participants in Cohort A received co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) every 6 weeks (Q6W) for up to approximately 2 years.
At the investigator's discretion, eligible participants randomized to the pembrolizumab/quavonlimab arm who completed the first course of pembrolizumab/quavonlimab or who had stopped pembrolizumab/quavonlimab due to confirmed complete response (CR) initiated a second course of pembrolizumab/quavonlimab (400 mg/25 mg) Q6W for up to approximately 1 additional year.
|
Cohort A - Pembrolizumab
n=61 Participants
Participants in Cohort A received pembrolizumab 400 mg intravenously (IV) Q6W for up to approximately 2 years.
At the investigator's discretion, eligible participants randomized to the pembrolizumab arm who completed the first course of pembrolizumab or who had stopped pembrolizumab due to confirmed CR initiated a second course of pembrolizumab 400 mg Q6W for up to approximately 1 additional year.
|
Cohort B - Pembrolizumab/Quavonlimab
n=39 Participants
Participants received co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) Q6W for up to approximately 2 years.
|
Cohort B - Pembrolizumab Plus MK-4830
n=20 Participants
Participants received pembrolizumab 200 mg plus MK-4830 800 mg Q3W for up to approximately 2 years.
|
Cohort B - Pembrolizumab/Favezelimab
n=40 Participants
Participants received co-formulated pembrolizumab/favezelimab (200 mg/800 mg) every 3 weeks (Q3W) for up to approximately 2 years.
|
Cohort B - Pembrolizumab/Vibostolimab
n=41 Participants
Participants received co-formulated pembrolizumab/vibostolimab (200 mg/200 mg) Q3W for up to approximately 2 years.
|
Cohort B - Pembrolizumab
n=41 Participants
Participants in Cohort B received pembrolizumab 400 mg IV Q6W for up to approximately 2 years.
|
|---|---|---|---|---|---|---|---|
|
Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by BICR
|
17.9 Months
Interval 4.2 to
NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
4.2 Months
Interval 2.2 to 14.6
|
NA Months
Interval 12.0 to
NA = Median and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
NA Months
Interval 2.2 to
NA = Median and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
8.3 Months
Interval 2.3 to
NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
24.7 Months
Interval 8.3 to
NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
NA Months
Interval 4.2 to
NA = Median and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
SECONDARY outcome
Timeframe: Up to approximately 46 monthsPopulation: All randomized participants were analyzed.
PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 or death from any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by investigator is presented.
Outcome measures
| Measure |
Cohort A - Pembrolizumab/Quavonlimab
n=60 Participants
Participants in Cohort A received co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) every 6 weeks (Q6W) for up to approximately 2 years.
At the investigator's discretion, eligible participants randomized to the pembrolizumab/quavonlimab arm who completed the first course of pembrolizumab/quavonlimab or who had stopped pembrolizumab/quavonlimab due to confirmed complete response (CR) initiated a second course of pembrolizumab/quavonlimab (400 mg/25 mg) Q6W for up to approximately 1 additional year.
|
Cohort A - Pembrolizumab
n=61 Participants
Participants in Cohort A received pembrolizumab 400 mg intravenously (IV) Q6W for up to approximately 2 years.
At the investigator's discretion, eligible participants randomized to the pembrolizumab arm who completed the first course of pembrolizumab or who had stopped pembrolizumab due to confirmed CR initiated a second course of pembrolizumab 400 mg Q6W for up to approximately 1 additional year.
|
Cohort B - Pembrolizumab/Quavonlimab
n=39 Participants
Participants received co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) Q6W for up to approximately 2 years.
|
Cohort B - Pembrolizumab Plus MK-4830
n=20 Participants
Participants received pembrolizumab 200 mg plus MK-4830 800 mg Q3W for up to approximately 2 years.
|
Cohort B - Pembrolizumab/Favezelimab
n=40 Participants
Participants received co-formulated pembrolizumab/favezelimab (200 mg/800 mg) every 3 weeks (Q3W) for up to approximately 2 years.
|
Cohort B - Pembrolizumab/Vibostolimab
n=41 Participants
Participants received co-formulated pembrolizumab/vibostolimab (200 mg/200 mg) Q3W for up to approximately 2 years.
|
Cohort B - Pembrolizumab
n=41 Participants
Participants in Cohort B received pembrolizumab 400 mg IV Q6W for up to approximately 2 years.
|
|---|---|---|---|---|---|---|---|
|
PFS Per RECIST 1.1 as Assessed by Investigator
|
9.4 Months
Interval 4.2 to 31.3
|
6.2 Months
Interval 2.2 to 33.4
|
24.7 Months
Interval 10.3 to
NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
NA Months
Interval 3.0 to
NA = Median and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
5.6 Months
Interval 2.1 to 26.9
|
24.7 Months
Interval 8.2 to
NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
20.8 Months
Interval 4.1 to
NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
SECONDARY outcome
Timeframe: Up to approximately 46 monthsPopulation: All randomized participants were analyzed.
ORR was defined as the percentage of participants who had a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR as assessed by investigator is be presented.
Outcome measures
| Measure |
Cohort A - Pembrolizumab/Quavonlimab
n=60 Participants
Participants in Cohort A received co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) every 6 weeks (Q6W) for up to approximately 2 years.
At the investigator's discretion, eligible participants randomized to the pembrolizumab/quavonlimab arm who completed the first course of pembrolizumab/quavonlimab or who had stopped pembrolizumab/quavonlimab due to confirmed complete response (CR) initiated a second course of pembrolizumab/quavonlimab (400 mg/25 mg) Q6W for up to approximately 1 additional year.
|
Cohort A - Pembrolizumab
n=61 Participants
Participants in Cohort A received pembrolizumab 400 mg intravenously (IV) Q6W for up to approximately 2 years.
At the investigator's discretion, eligible participants randomized to the pembrolizumab arm who completed the first course of pembrolizumab or who had stopped pembrolizumab due to confirmed CR initiated a second course of pembrolizumab 400 mg Q6W for up to approximately 1 additional year.
|
Cohort B - Pembrolizumab/Quavonlimab
n=39 Participants
Participants received co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) Q6W for up to approximately 2 years.
|
Cohort B - Pembrolizumab Plus MK-4830
n=20 Participants
Participants received pembrolizumab 200 mg plus MK-4830 800 mg Q3W for up to approximately 2 years.
|
Cohort B - Pembrolizumab/Favezelimab
n=40 Participants
Participants received co-formulated pembrolizumab/favezelimab (200 mg/800 mg) every 3 weeks (Q3W) for up to approximately 2 years.
|
Cohort B - Pembrolizumab/Vibostolimab
n=41 Participants
Participants received co-formulated pembrolizumab/vibostolimab (200 mg/200 mg) Q3W for up to approximately 2 years.
|
Cohort B - Pembrolizumab
n=41 Participants
Participants in Cohort B received pembrolizumab 400 mg IV Q6W for up to approximately 2 years.
|
|---|---|---|---|---|---|---|---|
|
ORR Per RECIST 1.1 as Assessed by Investigator
|
41.7 Percentage of Participants
Interval 29.1 to 55.1
|
27.9 Percentage of Participants
Interval 17.1 to 40.8
|
46.2 Percentage of Participants
Interval 30.1 to 62.8
|
60.0 Percentage of Participants
Interval 36.1 to 80.9
|
40.0 Percentage of Participants
Interval 24.9 to 56.7
|
53.7 Percentage of Participants
Interval 37.4 to 69.3
|
43.9 Percentage of Participants
Interval 28.5 to 60.3
|
SECONDARY outcome
Timeframe: Up to approximately 46 monthsPopulation: All participants who experienced CR or PR as assessed by Investigator were analyzed.
DOR was defined as the time from the first documented evidence of a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 until PD or death due to any cause, whichever occurs first, in participants demonstrating a CR or PR. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by investigator is presented.
Outcome measures
| Measure |
Cohort A - Pembrolizumab/Quavonlimab
n=25 Participants
Participants in Cohort A received co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) every 6 weeks (Q6W) for up to approximately 2 years.
At the investigator's discretion, eligible participants randomized to the pembrolizumab/quavonlimab arm who completed the first course of pembrolizumab/quavonlimab or who had stopped pembrolizumab/quavonlimab due to confirmed complete response (CR) initiated a second course of pembrolizumab/quavonlimab (400 mg/25 mg) Q6W for up to approximately 1 additional year.
|
Cohort A - Pembrolizumab
n=17 Participants
Participants in Cohort A received pembrolizumab 400 mg intravenously (IV) Q6W for up to approximately 2 years.
At the investigator's discretion, eligible participants randomized to the pembrolizumab arm who completed the first course of pembrolizumab or who had stopped pembrolizumab due to confirmed CR initiated a second course of pembrolizumab 400 mg Q6W for up to approximately 1 additional year.
|
Cohort B - Pembrolizumab/Quavonlimab
n=18 Participants
Participants received co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) Q6W for up to approximately 2 years.
|
Cohort B - Pembrolizumab Plus MK-4830
n=12 Participants
Participants received pembrolizumab 200 mg plus MK-4830 800 mg Q3W for up to approximately 2 years.
|
Cohort B - Pembrolizumab/Favezelimab
n=16 Participants
Participants received co-formulated pembrolizumab/favezelimab (200 mg/800 mg) every 3 weeks (Q3W) for up to approximately 2 years.
|
Cohort B - Pembrolizumab/Vibostolimab
n=22 Participants
Participants received co-formulated pembrolizumab/vibostolimab (200 mg/200 mg) Q3W for up to approximately 2 years.
|
Cohort B - Pembrolizumab
n=18 Participants
Participants in Cohort B received pembrolizumab 400 mg IV Q6W for up to approximately 2 years.
|
|---|---|---|---|---|---|---|---|
|
DOR Per RECIST 1.1 as Assessed by Investigator
|
NA Months
NA = Median, upper limit, and lower limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
|
35.3 Months
Interval 33.4 to
NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
|
NA Months
NA = Median, upper limit, and lower limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
|
NA Months
NA = Median, upper limit, and lower limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
|
25.0 Months
Interval 10.3 to
NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
|
NA Months
NA = Median, upper limit, and lower limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
|
NA Months
Interval 18.7 to
NA = Median and upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
|
SECONDARY outcome
Timeframe: Up to approximately 46 monthsPopulation: All randomized participants were analyzed.
OS was defined as the time from randomization (or first dose) to death due to any cause. OS is presented.
Outcome measures
| Measure |
Cohort A - Pembrolizumab/Quavonlimab
n=60 Participants
Participants in Cohort A received co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) every 6 weeks (Q6W) for up to approximately 2 years.
At the investigator's discretion, eligible participants randomized to the pembrolizumab/quavonlimab arm who completed the first course of pembrolizumab/quavonlimab or who had stopped pembrolizumab/quavonlimab due to confirmed complete response (CR) initiated a second course of pembrolizumab/quavonlimab (400 mg/25 mg) Q6W for up to approximately 1 additional year.
|
Cohort A - Pembrolizumab
n=61 Participants
Participants in Cohort A received pembrolizumab 400 mg intravenously (IV) Q6W for up to approximately 2 years.
At the investigator's discretion, eligible participants randomized to the pembrolizumab arm who completed the first course of pembrolizumab or who had stopped pembrolizumab due to confirmed CR initiated a second course of pembrolizumab 400 mg Q6W for up to approximately 1 additional year.
|
Cohort B - Pembrolizumab/Quavonlimab
n=39 Participants
Participants received co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) Q6W for up to approximately 2 years.
|
Cohort B - Pembrolizumab Plus MK-4830
n=20 Participants
Participants received pembrolizumab 200 mg plus MK-4830 800 mg Q3W for up to approximately 2 years.
|
Cohort B - Pembrolizumab/Favezelimab
n=40 Participants
Participants received co-formulated pembrolizumab/favezelimab (200 mg/800 mg) every 3 weeks (Q3W) for up to approximately 2 years.
|
Cohort B - Pembrolizumab/Vibostolimab
n=41 Participants
Participants received co-formulated pembrolizumab/vibostolimab (200 mg/200 mg) Q3W for up to approximately 2 years.
|
Cohort B - Pembrolizumab
n=41 Participants
Participants in Cohort B received pembrolizumab 400 mg IV Q6W for up to approximately 2 years.
|
|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
NA Months
Interval 29.0 to
NA = Median and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
37.1 Months
Interval 14.4 to
NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
NA Months
NA = Median, upper limit, and lower limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
NA Months
Interval 6.9 to
NA = Median and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
NA Months
Interval 21.2 to
NA = Median and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
NA Months
NA = Median, upper limit, and lower limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
NA Months
Interval 21.2 to
NA = Median and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
SECONDARY outcome
Timeframe: Up to approximately 60 monthsAn AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study intervention. The number of participants with an AE is presented.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 60 monthsAn AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study intervention. The number of participants that discontinue study treatment due to an AE is presented.
Outcome measures
Outcome data not reported
Adverse Events
Cohort A: Pembrolizumab/Quavonlimab First Course
Serious events: 17 serious events
Other events: 52 other events
Deaths: 23 deaths
Cohort A: Pembrolizumab First Course
Serious events: 12 serious events
Other events: 47 other events
Deaths: 30 deaths
Cohort B: Pembrolizumab/Quavonlimab
Serious events: 14 serious events
Other events: 34 other events
Deaths: 11 deaths
Cohort B: Pembrolizumab Plus MK-4830
Serious events: 3 serious events
Other events: 20 other events
Deaths: 7 deaths
Cohort B: Pembrolizumab/Favezelimab
Serious events: 14 serious events
Other events: 34 other events
Deaths: 12 deaths
Cohort B: Pembrolizumab/Vibostolimab
Serious events: 13 serious events
Other events: 38 other events
Deaths: 9 deaths
Cohort B: Pembrolizumab
Serious events: 13 serious events
Other events: 32 other events
Deaths: 11 deaths
Cohort A: Pembrolizumab/Quavonlimab Second Course
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort A: Pembrolizumab Second Course
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A: Pembrolizumab/Quavonlimab First Course
n=60 participants at risk
Participants in Cohort A received co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) every 6 weeks (Q6W) for up to approximately 2 years.
|
Cohort A: Pembrolizumab First Course
n=60 participants at risk
Participants in Cohort A received pembrolizumab 400 mg intravenously (IV) Q6W for up to approximately 2 years
|
Cohort B: Pembrolizumab/Quavonlimab
n=39 participants at risk
Participants received co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) Q6W for up to approximately 2 years.
|
Cohort B: Pembrolizumab Plus MK-4830
n=20 participants at risk
Participants received pembrolizumab 200 mg plus MK-4830 800 mg Q3W for up to approximately 2 years
|
Cohort B: Pembrolizumab/Favezelimab
n=40 participants at risk
Participants received co-formulated pembrolizumab/favezelimab (200 mg/800 mg) every 3 weeks (Q3W) for up to approximately 2 years.
|
Cohort B: Pembrolizumab/Vibostolimab
n=41 participants at risk
Participants received co-formulated pembrolizumab/vibostolimab (200 mg/200 mg) Q3W for up to approximately 2 years.
|
Cohort B: Pembrolizumab
n=41 participants at risk
Participants in Cohort B received pembrolizumab 400 mg IV Q6W for up to approximately 2 years.
|
Cohort A: Pembrolizumab/Quavonlimab Second Course
n=1 participants at risk
At the investigator's discretion, eligible participants randomized to the pembrolizumab/quavonlimab arm who completed the first course of pembrolizumab/quavonlimab or who had stopped pembrolizumab/quavonlimab due to confirmed complete response (CR) initiated a second course of pembrolizumab/quavonlimab (400 mg/25 mg) Q6W for up to approximately 1 additional year.
|
Cohort A: Pembrolizumab Second Course
n=3 participants at risk
At the investigator's discretion, eligible participants randomized to the pembrolizumab arm who completed the first course of pembrolizumab or who had stopped pembrolizumab due to confirmed CR initiated a second course of pembrolizumab 400 mg Q6W for up to approximately 1 additional year.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
3.3%
2/60 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Cardiac disorders
Angina unstable
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Cardiac disorders
Myocardial infarction
|
5.0%
3/60 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Endocrine disorders
Hypophysitis
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.6%
1/39 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.5%
1/40 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.5%
1/40 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Gastrointestinal disorders
Colonic fistula
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.6%
1/39 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.5%
1/40 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.5%
3/40 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.5%
1/40 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.6%
1/39 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.3%
3/41 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.6%
1/39 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
3.3%
2/60 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.6%
1/39 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.5%
1/40 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.6%
1/39 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.5%
1/40 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
General disorders
Chest pain
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
General disorders
Death
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.6%
1/39 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
4.9%
2/41 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
General disorders
Fatigue
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
General disorders
General physical health deterioration
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.6%
1/39 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
General disorders
Malaise
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.5%
1/40 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.6%
1/39 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.6%
1/39 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.6%
1/39 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.5%
1/40 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.6%
1/39 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
10.0%
2/20 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
1/20 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.6%
1/39 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Infections and infestations
Campylobacter infection
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.6%
1/39 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
4.9%
2/41 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.5%
1/40 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Infections and infestations
Septic shock
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Infections and infestations
Skin infection
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Infections and infestations
Viral infection
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.5%
1/40 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.6%
1/39 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
2/40 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.5%
1/40 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.6%
1/39 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Musculoskeletal and connective tissue disorders
Immune-mediated arthritis
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.6%
1/39 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.6%
1/39 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.6%
1/39 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.5%
1/40 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.6%
1/39 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Nervous system disorders
Immune-mediated encephalitis
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Nervous system disorders
Monoparesis
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.6%
1/39 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.6%
1/39 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Renal and urinary disorders
Hydronephrosis
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Renal and urinary disorders
Nephropathy
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
100.0%
1/1 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.6%
1/39 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.5%
1/40 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.5%
1/40 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Vascular disorders
Embolism
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
Other adverse events
| Measure |
Cohort A: Pembrolizumab/Quavonlimab First Course
n=60 participants at risk
Participants in Cohort A received co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) every 6 weeks (Q6W) for up to approximately 2 years.
|
Cohort A: Pembrolizumab First Course
n=60 participants at risk
Participants in Cohort A received pembrolizumab 400 mg intravenously (IV) Q6W for up to approximately 2 years
|
Cohort B: Pembrolizumab/Quavonlimab
n=39 participants at risk
Participants received co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) Q6W for up to approximately 2 years.
|
Cohort B: Pembrolizumab Plus MK-4830
n=20 participants at risk
Participants received pembrolizumab 200 mg plus MK-4830 800 mg Q3W for up to approximately 2 years
|
Cohort B: Pembrolizumab/Favezelimab
n=40 participants at risk
Participants received co-formulated pembrolizumab/favezelimab (200 mg/800 mg) every 3 weeks (Q3W) for up to approximately 2 years.
|
Cohort B: Pembrolizumab/Vibostolimab
n=41 participants at risk
Participants received co-formulated pembrolizumab/vibostolimab (200 mg/200 mg) Q3W for up to approximately 2 years.
|
Cohort B: Pembrolizumab
n=41 participants at risk
Participants in Cohort B received pembrolizumab 400 mg IV Q6W for up to approximately 2 years.
|
Cohort A: Pembrolizumab/Quavonlimab Second Course
n=1 participants at risk
At the investigator's discretion, eligible participants randomized to the pembrolizumab/quavonlimab arm who completed the first course of pembrolizumab/quavonlimab or who had stopped pembrolizumab/quavonlimab due to confirmed complete response (CR) initiated a second course of pembrolizumab/quavonlimab (400 mg/25 mg) Q6W for up to approximately 1 additional year.
|
Cohort A: Pembrolizumab Second Course
n=3 participants at risk
At the investigator's discretion, eligible participants randomized to the pembrolizumab arm who completed the first course of pembrolizumab or who had stopped pembrolizumab due to confirmed CR initiated a second course of pembrolizumab 400 mg Q6W for up to approximately 1 additional year.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
26.7%
16/60 • Number of events 21 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
18.3%
11/60 • Number of events 12 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
20.5%
8/39 • Number of events 8 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
25.0%
5/20 • Number of events 6 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
12.5%
5/40 • Number of events 7 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
19.5%
8/41 • Number of events 8 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
19.5%
8/41 • Number of events 12 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
100.0%
1/1 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.6%
1/39 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.3%
3/41 • Number of events 4 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.7%
1/60 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
3.3%
2/60 • Number of events 5 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
4.9%
2/41 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
100.0%
1/1 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Endocrine disorders
Adrenal insufficiency
|
6.7%
4/60 • Number of events 5 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
3.3%
2/60 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.7%
3/39 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
1/20 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.5%
1/40 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
9.8%
4/41 • Number of events 4 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
4.9%
2/41 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
11.7%
7/60 • Number of events 8 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
3.3%
2/60 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.1%
2/39 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
20.0%
4/20 • Number of events 4 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
20.0%
8/40 • Number of events 9 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
26.8%
11/41 • Number of events 12 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Endocrine disorders
Hypothyroidism
|
23.3%
14/60 • Number of events 19 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
15.0%
9/60 • Number of events 9 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
15.4%
6/39 • Number of events 6 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
30.0%
6/20 • Number of events 6 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
27.5%
11/40 • Number of events 11 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
22.0%
9/41 • Number of events 9 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
4.9%
2/41 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
4/60 • Number of events 4 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
3/60 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
15.4%
6/39 • Number of events 6 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
1/20 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
2/40 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
9.8%
4/41 • Number of events 8 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
12.2%
5/41 • Number of events 5 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
8.3%
5/60 • Number of events 7 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.7%
3/39 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
1/20 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Gastrointestinal disorders
Constipation
|
3.3%
2/60 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
3/60 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
15.4%
6/39 • Number of events 8 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.5%
1/40 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
12.2%
5/41 • Number of events 8 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.3%
3/41 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.7%
7/60 • Number of events 11 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
11.7%
7/60 • Number of events 11 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
20.5%
8/39 • Number of events 11 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
15.0%
3/20 • Number of events 11 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
17.5%
7/40 • Number of events 8 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
14.6%
6/41 • Number of events 14 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
24.4%
10/41 • Number of events 17 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
66.7%
2/3 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
10.3%
4/39 • Number of events 5 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
2/40 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
4.9%
2/41 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
3.3%
2/60 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.1%
2/39 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
1/20 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.3%
3/41 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
1/20 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.5%
1/40 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
9.8%
4/41 • Number of events 4 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
4.9%
2/41 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
4/60 • Number of events 6 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
6.7%
4/60 • Number of events 4 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
15.4%
6/39 • Number of events 11 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
1/20 • Number of events 4 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.5%
3/40 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
12.2%
5/41 • Number of events 8 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
9.8%
4/41 • Number of events 6 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
100.0%
1/1 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.7%
3/39 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
2/60 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
6.7%
4/60 • Number of events 4 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
10.3%
4/39 • Number of events 6 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
1/20 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
2/40 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
12.2%
5/41 • Number of events 6 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
9.8%
4/41 • Number of events 7 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
General disorders
Asthenia
|
6.7%
4/60 • Number of events 6 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
13.3%
8/60 • Number of events 8 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
17.9%
7/39 • Number of events 7 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
1/20 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
10.0%
4/40 • Number of events 7 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
4.9%
2/41 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
12.2%
5/41 • Number of events 6 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
100.0%
3/3 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
General disorders
Fatigue
|
20.0%
12/60 • Number of events 12 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
6.7%
4/60 • Number of events 4 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
23.1%
9/39 • Number of events 11 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
10.0%
2/20 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
12.5%
5/40 • Number of events 6 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
19.5%
8/41 • Number of events 9 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
14.6%
6/41 • Number of events 6 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
100.0%
1/1 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
General disorders
Influenza like illness
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
10.3%
4/39 • Number of events 5 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
1/20 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
2/40 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
4.9%
2/41 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
General disorders
Mucosal inflammation
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.1%
2/39 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
4.9%
2/41 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
3.3%
2/60 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
12.8%
5/39 • Number of events 6 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
10.0%
2/20 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
2/40 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
General disorders
Pyrexia
|
6.7%
4/60 • Number of events 4 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
3/60 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.6%
1/39 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
10.0%
2/20 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
15.0%
6/40 • Number of events 7 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
9.8%
4/41 • Number of events 6 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
4.9%
2/41 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Infections and infestations
COVID-19
|
3.3%
2/60 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.6%
1/39 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
10.0%
2/20 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
4.9%
2/41 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.3%
3/41 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
10.3%
4/39 • Number of events 5 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.3%
3/41 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.1%
2/39 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
4.9%
2/41 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.3%
2/60 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.1%
2/39 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
1/20 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.5%
3/40 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
9.8%
4/41 • Number of events 4 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Infections and infestations
Urinary tract infection
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
3.3%
2/60 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.1%
2/39 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
10.0%
2/20 • Number of events 11 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
4.9%
2/41 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
100.0%
1/1 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
100.0%
1/1 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
100.0%
1/1 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
12/60 • Number of events 16 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
6.7%
4/60 • Number of events 5 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
15.4%
6/39 • Number of events 7 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
10.0%
2/20 • Number of events 9 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
20.0%
8/40 • Number of events 10 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
14.6%
6/41 • Number of events 8 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.3%
3/41 • Number of events 5 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Investigations
Amylase increased
|
8.3%
5/60 • Number of events 7 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
2/40 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
4.9%
2/41 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.3%
3/41 • Number of events 4 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
100.0%
1/1 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
12/60 • Number of events 12 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
6.7%
4/60 • Number of events 6 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
12.8%
5/39 • Number of events 7 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
20.0%
4/20 • Number of events 10 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
12.5%
5/40 • Number of events 5 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
19.5%
8/41 • Number of events 9 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.3%
3/41 • Number of events 5 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.0%
3/60 • Number of events 6 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
6.7%
4/60 • Number of events 6 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.7%
3/39 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
12.5%
5/40 • Number of events 5 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
4.9%
2/41 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
100.0%
1/1 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Investigations
Blood bilirubin increased
|
5.0%
3/60 • Number of events 6 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
3.3%
2/60 • Number of events 7 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.7%
3/39 • Number of events 4 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
15.0%
3/20 • Number of events 7 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
2/40 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Investigations
Blood creatinine increased
|
6.7%
4/60 • Number of events 5 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
8.3%
5/60 • Number of events 5 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.7%
3/39 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
1/20 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.5%
3/40 • Number of events 5 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.3%
3/41 • Number of events 4 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.3%
2/60 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.5%
1/40 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
100.0%
1/1 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Investigations
Lipase increased
|
3.3%
2/60 • Number of events 4 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.6%
1/39 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
1/20 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.5%
3/40 • Number of events 4 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.3%
3/41 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.3%
3/41 • Number of events 5 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
100.0%
1/1 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Investigations
Weight decreased
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
10.0%
6/60 • Number of events 6 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.6%
1/39 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
1/20 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.5%
1/40 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
4.9%
2/41 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
12.2%
5/41 • Number of events 6 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Investigations
Weight increased
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
10.0%
2/20 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.5%
1/40 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.3%
3/41 • Number of events 6 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.3%
3/41 • Number of events 4 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.7%
7/60 • Number of events 8 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
6.7%
4/60 • Number of events 4 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
23.1%
9/39 • Number of events 11 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
10.0%
2/20 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.5%
1/40 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
14.6%
6/41 • Number of events 6 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
12.2%
5/41 • Number of events 5 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.3%
2/60 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.1%
2/39 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.3%
3/41 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.0%
3/60 • Number of events 4 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.6%
1/39 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
1/20 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.3%
3/41 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.0%
3/60 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.1%
2/39 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.3%
3/41 • Number of events 4 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
100.0%
1/1 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.1%
2/39 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.3%
2/60 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.1%
2/39 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.5%
1/40 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.3%
3/41 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Metabolism and nutrition disorders
Hypophagia
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
100.0%
1/1 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
5/60 • Number of events 6 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
10.0%
6/60 • Number of events 7 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
15.4%
6/39 • Number of events 7 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
15.0%
3/20 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
12.2%
5/41 • Number of events 6 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
14.6%
6/41 • Number of events 10 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
66.7%
2/3 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
3.3%
2/60 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.6%
1/39 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
5/60 • Number of events 5 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
10.0%
6/60 • Number of events 6 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.7%
3/39 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
20.0%
4/20 • Number of events 4 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
10.0%
4/40 • Number of events 4 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.1%
2/39 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
1/20 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.3%
2/60 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
3.3%
2/60 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.1%
2/39 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
20.0%
4/20 • Number of events 5 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
2/40 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.3%
3/41 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
10.0%
2/20 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Nervous system disorders
Dizziness
|
5.0%
3/60 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.1%
2/39 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
10.0%
2/20 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.3%
3/41 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Nervous system disorders
Headache
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
3/60 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.7%
3/39 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
2/40 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
19.5%
8/41 • Number of events 8 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Psychiatric disorders
Depression
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.3%
3/41 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.7%
3/39 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.5%
1/40 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
4.9%
2/41 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Reproductive system and breast disorders
Painful ejaculation
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.1%
2/39 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
2/40 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.3%
3/41 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
4.9%
2/41 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
3.3%
2/60 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.1%
2/39 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.5%
1/40 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.0%
3/60 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.7%
3/39 • Number of events 4 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.5%
3/40 • Number of events 4 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
1/20 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.5%
3/40 • Number of events 5 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
4.9%
2/41 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.7%
3/39 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
10.0%
2/20 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
4.9%
2/41 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.1%
2/39 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
4.9%
2/41 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.3%
2/60 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.1%
2/39 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.5%
1/40 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
4.9%
2/41 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
100.0%
1/1 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/60 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.3%
3/41 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
26.7%
16/60 • Number of events 20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
11.7%
7/60 • Number of events 7 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
38.5%
15/39 • Number of events 21 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
1/20 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
20.0%
8/40 • Number of events 11 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
36.6%
15/41 • Number of events 23 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
14.6%
6/41 • Number of events 6 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
100.0%
1/1 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
66.7%
2/3 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.3%
8/60 • Number of events 8 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
3.3%
2/60 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.6%
1/39 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
15.0%
3/20 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
10.0%
4/40 • Number of events 4 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
19.5%
8/41 • Number of events 10 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
10.3%
4/39 • Number of events 4 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
1/20 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.3%
3/41 • Number of events 4 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.3%
2/60 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
1.7%
1/60 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/39 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/20 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/40 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
2.4%
1/41 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
|
Vascular disorders
Hypertension
|
5.0%
3/60 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
6.7%
4/60 • Number of events 4 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.7%
3/39 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
1/20 • Number of events 1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
5.0%
2/40 • Number of events 2 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
7.3%
3/41 • Number of events 3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/41 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/1 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
0.00%
0/3 • Up to approximately 46 months
All-Cause Mortality (ACM) includes all randomized participants. AEs include all randomized participants who received ≥1 dose of study treatment. Progression of the cancer under study was not considered an AE unless related to study drug. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs. Data are reported by treatment received. ACM and AEs are reported separately for second course treatment.
|
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 Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER