Trial Outcomes & Findings for A Study of Pembrolizumab (MK-3475) in Participants With Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-059/KEYNOTE-059) (NCT NCT02335411)
NCT ID: NCT02335411
Last Updated: 2022-08-08
Results Overview
An AE is defined as any untoward medical occurrence in a participant administered study drug and which does not necessarily have to have a causal relationship with the study drug. The number of participants who experienced at least one AE is presented. Per protocol, the number of participants who experienced at least one AE during first course pembrolizumab treatment is presented.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
318 participants
Primary outcome timeframe
Up to approximately 65 months
Results posted on
2022-08-08
Participant Flow
Male and female participants of at least 18 years of age with recurrent or metastatic gastric or gastro-esophageal junction (GEJ) adenocarcinoma were enrolled in this study.
318 participants were originally allocated to the study. No study information was collected from 3 participants, who were excluded from all analyses, including disposition. Per protocol, response/progression or adverse events during the second pembrolizumab course were not counted towards efficacy outcome measures or safety outcome measures respectively.
Participant milestones
| Measure |
Cohort 1: Pembrolizumab Monotherapy, Previously Treated
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
Cohort 2: Pembrolizumab Combination Therapy, Treatment Naive
Participants received pembrolizumab 200 mg IV each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m\^2 IV Q3W for up to 6 cycles + 5-Fluorouracil (5-FU) 800 mg/m\^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m\^2 orally, twice per day (BID) on Days 1-14 of each 3-week cycle. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
Cohort 3: Pembrolizumab Monotherapy, Treatment Naive, PD-L1 Positive
Programmed death-ligand 1 (PD-L1) positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
|---|---|---|---|
|
Overall Study
STARTED
|
259
|
25
|
31
|
|
Overall Study
Second Course Pembrolizumab
|
3
|
1
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
259
|
25
|
31
|
Reasons for withdrawal
| Measure |
Cohort 1: Pembrolizumab Monotherapy, Previously Treated
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
Cohort 2: Pembrolizumab Combination Therapy, Treatment Naive
Participants received pembrolizumab 200 mg IV each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m\^2 IV Q3W for up to 6 cycles + 5-Fluorouracil (5-FU) 800 mg/m\^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m\^2 orally, twice per day (BID) on Days 1-14 of each 3-week cycle. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
Cohort 3: Pembrolizumab Monotherapy, Treatment Naive, PD-L1 Positive
Programmed death-ligand 1 (PD-L1) positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
|---|---|---|---|
|
Overall Study
Death
|
223
|
22
|
26
|
|
Overall Study
Physician Decision
|
3
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
11
|
0
|
3
|
|
Overall Study
Sponsor Decision
|
12
|
3
|
2
|
|
Overall Study
Adverse Event
|
9
|
0
|
0
|
Baseline Characteristics
A Study of Pembrolizumab (MK-3475) in Participants With Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-059/KEYNOTE-059)
Baseline characteristics by cohort
| Measure |
Cohort 1: Pembrolizumab Monotherapy, Previously Treated
n=259 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
Cohort 2: Pembrolizumab Combination Therapy, Treatment Naive
n=25 Participants
Participants received pembrolizumab 200 mg IV each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m\^2 IV Q3W for up to 6 cycles + 5-Fluorouracil (5-FU) 800 mg/m\^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m\^2 orally, twice per day (BID) on Days 1-14 of each 3-week cycle. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
Cohort 3: Pembrolizumab Monotherapy, Treatment Naive, PD-L1 Positive
n=31 Participants
Programmed death-ligand 1 (PD-L1) positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
Total
n=315 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.0 Years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
58.8 Years
STANDARD_DEVIATION 16.6 • n=7 Participants
|
60.3 Years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
60.7 Years
STANDARD_DEVIATION 11.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
198 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
233 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
228 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
279 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
41 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
200 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
224 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 65 monthsPopulation: All enrolled participants who received ≥1 dose of study drug.
An AE is defined as any untoward medical occurrence in a participant administered study drug and which does not necessarily have to have a causal relationship with the study drug. The number of participants who experienced at least one AE is presented. Per protocol, the number of participants who experienced at least one AE during first course pembrolizumab treatment is presented.
Outcome measures
| Measure |
Cohort 1: Pembrolizumab Monotherapy, Previously Treated
n=259 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
Cohort 2: Pembrolizumab Combination Therapy, Treatment Naive
n=25 Participants
Participants received pembrolizumab 200 mg IV each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m\^2 IV Q3W for up to 6 cycles + 5-Fluorouracil (5-FU) 800 mg/m\^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m\^2 orally, twice per day (BID) on Days 1-14 of each 3-week cycle. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
Cohort 3: Pembrolizumab Monotherapy, Treatment Naive, PD-L1 Positive
n=31 Participants
Programmed death-ligand 1 (PD-L1) positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
|---|---|---|---|
|
Number of Participants Experiencing Adverse Events (AEs)
|
248 Participants
|
25 Participants
|
31 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 52 monthsPopulation: All enrolled participants who received ≥1 dose of study drug.
An AE was defined as any untoward medical occurrence in a participant administered study drug and which does not necessarily have to have a causal relationship with the study drug. The number of participants who discontinued study drug due to an AE is presented. Per protocol, the number of participants who discontinued drug during first course pembrolizumab treatment is presented.
Outcome measures
| Measure |
Cohort 1: Pembrolizumab Monotherapy, Previously Treated
n=259 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
Cohort 2: Pembrolizumab Combination Therapy, Treatment Naive
n=25 Participants
Participants received pembrolizumab 200 mg IV each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m\^2 IV Q3W for up to 6 cycles + 5-Fluorouracil (5-FU) 800 mg/m\^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m\^2 orally, twice per day (BID) on Days 1-14 of each 3-week cycle. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
Cohort 3: Pembrolizumab Monotherapy, Treatment Naive, PD-L1 Positive
n=31 Participants
Programmed death-ligand 1 (PD-L1) positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
|---|---|---|---|
|
Number of Participants Discontinuing Study Drug Due to AEs
|
18 Participants
|
4 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 75 monthsPopulation: All enrolled participants in Cohorts 1 and 3 who received ≥1 dose of study drug. Per protocol, Cohort 2 was not included in this outcome measure.
The Objective Response Rate (ORR) was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by central radiology review. The percentage of all participants (regardless of programmed death-ligand 1 \[PD-L1\] tumor status) in Cohorts 1 and 3 who had a CR or PR during first course pembrolizumab treatment per protocol, is presented.
Outcome measures
| Measure |
Cohort 1: Pembrolizumab Monotherapy, Previously Treated
n=259 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
Cohort 2: Pembrolizumab Combination Therapy, Treatment Naive
Participants received pembrolizumab 200 mg IV each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m\^2 IV Q3W for up to 6 cycles + 5-Fluorouracil (5-FU) 800 mg/m\^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m\^2 orally, twice per day (BID) on Days 1-14 of each 3-week cycle. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
Cohort 3: Pembrolizumab Monotherapy, Treatment Naive, PD-L1 Positive
n=31 Participants
Programmed death-ligand 1 (PD-L1) positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
|---|---|---|---|
|
Objective Response Rate (ORR) For All Participants in Cohorts 1 and 3
|
11.6 Percentage of Participants
Interval 8.0 to 16.1
|
—
|
22.6 Percentage of Participants
Interval 9.6 to 41.1
|
PRIMARY outcome
Timeframe: Up to approximately 75 monthsPopulation: All enrolled participants in Cohorts 1 and 3 with a positive PD-L1 tumor status who received ≥1 dose of study drug. Per protocol, Cohort 2 was not included in this outcome measure.
The ORR was defined as the percentage of participants in the analysis population who had a CR or PR (CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, as assessed by central radiology review. The percentage of all participants in Cohorts 1 and 3 with PD-L1+ tumor status who experienced a CR or PR during first course pembrolizumab treatment per protocol, is presented. Note: All participants in Cohort 3 had a PD-L1-positive tumor status.
Outcome measures
| Measure |
Cohort 1: Pembrolizumab Monotherapy, Previously Treated
n=148 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
Cohort 2: Pembrolizumab Combination Therapy, Treatment Naive
Participants received pembrolizumab 200 mg IV each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m\^2 IV Q3W for up to 6 cycles + 5-Fluorouracil (5-FU) 800 mg/m\^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m\^2 orally, twice per day (BID) on Days 1-14 of each 3-week cycle. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
Cohort 3: Pembrolizumab Monotherapy, Treatment Naive, PD-L1 Positive
n=31 Participants
Programmed death-ligand 1 (PD-L1) positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
|---|---|---|---|
|
Objective Response Rate For PD-L1 Positive Participants in Cohorts 1 and 3
|
15.5 Percentage of Participants
Interval 10.1 to 22.4
|
—
|
22.6 Percentage of Participants
Interval 9.6 to 41.1
|
SECONDARY outcome
Timeframe: Up to approximately 75 monthsPopulation: All enrolled participants in Cohort 2 who received ≥1 dose of study drug. Per protocol, Cohorts 1 and 3 were not included in this outcome measure.
The Objective Response Rate (ORR) was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by central radiology review. The percentage of all participants (regardless of PD-L1 tumor status) in Cohort 2 who had a CR or PR during first course pembrolizumab treatment per protocol, is presented.
Outcome measures
| Measure |
Cohort 1: Pembrolizumab Monotherapy, Previously Treated
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
Cohort 2: Pembrolizumab Combination Therapy, Treatment Naive
n=25 Participants
Participants received pembrolizumab 200 mg IV each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m\^2 IV Q3W for up to 6 cycles + 5-Fluorouracil (5-FU) 800 mg/m\^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m\^2 orally, twice per day (BID) on Days 1-14 of each 3-week cycle. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
Cohort 3: Pembrolizumab Monotherapy, Treatment Naive, PD-L1 Positive
Programmed death-ligand 1 (PD-L1) positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
|---|---|---|---|
|
Objective Response Rate (ORR) For All Participants in Cohort 2
|
—
|
60.0 Percentage of Participants
Interval 38.7 to 78.9
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 75 monthsPopulation: All enrolled participants in Cohort 2 with a positive PD-L1 tumor status who received ≥1 dose of study drug. Per protocol, Cohorts 1 and 3 were not included in this outcome measure.
The ORR was defined as the percentage of participants in the analysis population who had a CR or PR (CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, as assessed by central radiology review. The percentage of participants in Cohort 2 with PD-L1+ tumor status who experienced a CR or PR during first course pembrolizumab treatment per protocol, is presented.
Outcome measures
| Measure |
Cohort 1: Pembrolizumab Monotherapy, Previously Treated
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
Cohort 2: Pembrolizumab Combination Therapy, Treatment Naive
n=15 Participants
Participants received pembrolizumab 200 mg IV each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m\^2 IV Q3W for up to 6 cycles + 5-Fluorouracil (5-FU) 800 mg/m\^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m\^2 orally, twice per day (BID) on Days 1-14 of each 3-week cycle. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
Cohort 3: Pembrolizumab Monotherapy, Treatment Naive, PD-L1 Positive
Programmed death-ligand 1 (PD-L1) positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
|---|---|---|---|
|
Objective Response Rate For PD-L1 Positive Participants in Cohort 2
|
—
|
73.3 Percentage of Participants
Interval 44.9 to 92.2
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 75 monthsPopulation: All enrolled participants who received ≥1 dose of study drug and demonstrated a confirmed response (CR or PR).
Duration of Response (DOR) was defined as the time from first documented evidence of CR or PR (CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, based on central imaging vendor assessment, until disease progression (PD) or death, whichever occurred first. PD is defined as ≥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 ≥5 mm. The appearance of one or more new lesions is also considered PD. Participants who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment. The DOR for all participants (regardless of PD-L1 tumor status) during first course pembrolizumab treatment per protocol, is presented.
Outcome measures
| Measure |
Cohort 1: Pembrolizumab Monotherapy, Previously Treated
n=30 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
Cohort 2: Pembrolizumab Combination Therapy, Treatment Naive
n=15 Participants
Participants received pembrolizumab 200 mg IV each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m\^2 IV Q3W for up to 6 cycles + 5-Fluorouracil (5-FU) 800 mg/m\^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m\^2 orally, twice per day (BID) on Days 1-14 of each 3-week cycle. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
Cohort 3: Pembrolizumab Monotherapy, Treatment Naive, PD-L1 Positive
n=7 Participants
Programmed death-ligand 1 (PD-L1) positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
|---|---|---|---|
|
Duration of Response (DOR) For All Participants
|
16.1 Months
Interval 2.4 to
NA = upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
|
4.6 Months
Interval 2.6 to
NA = upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
|
38.0 Months
Interval 2.1 to
NA = 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 75 monthsPopulation: All enrolled participants with a positive PD-L1 tumor status who received ≥1 dose of study drug and demonstrated a confirmed response (CR or PR).
DOR was defined as the time from first documented evidence of CR or PR (CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, based on central imaging vendor assessment, until disease progression (PD) or death, whichever occurred first. PD is defined as ≥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 ≥5 mm. The appearance of one or more new lesions is also considered PD. Participants who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment. The DOR for only PD-L1 positive participants during first course pembrolizumab treatment per protocol, is presented. Note: All participants in Cohort 3 had a PD-L1-positive tumor status.
Outcome measures
| Measure |
Cohort 1: Pembrolizumab Monotherapy, Previously Treated
n=23 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
Cohort 2: Pembrolizumab Combination Therapy, Treatment Naive
n=11 Participants
Participants received pembrolizumab 200 mg IV each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m\^2 IV Q3W for up to 6 cycles + 5-Fluorouracil (5-FU) 800 mg/m\^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m\^2 orally, twice per day (BID) on Days 1-14 of each 3-week cycle. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
Cohort 3: Pembrolizumab Monotherapy, Treatment Naive, PD-L1 Positive
n=7 Participants
Programmed death-ligand 1 (PD-L1) positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
|---|---|---|---|
|
Duration of Response For PD-L1 Positive Participants
|
NA Months
NA = median, upper and lower limits not reached at time of data cut-off due to insufficient number of responding participants with relapse.
|
4.6 Months
Interval 3.2 to
NA = upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
|
38.0 Months
Interval 2.1 to
NA = 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 75 monthsPopulation: All enrolled participants who received ≥1 dose of study drug.
Progression-Free Survival (PFS) was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. 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 progression. The PFS for all participants (regardless of PD-L1 tumor status) during first course pembrolizumab treatment per protocol, is presented.
Outcome measures
| Measure |
Cohort 1: Pembrolizumab Monotherapy, Previously Treated
n=259 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
Cohort 2: Pembrolizumab Combination Therapy, Treatment Naive
n=25 Participants
Participants received pembrolizumab 200 mg IV each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m\^2 IV Q3W for up to 6 cycles + 5-Fluorouracil (5-FU) 800 mg/m\^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m\^2 orally, twice per day (BID) on Days 1-14 of each 3-week cycle. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
Cohort 3: Pembrolizumab Monotherapy, Treatment Naive, PD-L1 Positive
n=31 Participants
Programmed death-ligand 1 (PD-L1) positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
|---|---|---|---|
|
Progression-Free Survival (PFS) For All Participants
|
2.0 Months
Interval 2.0 to 2.0
|
6.6 Months
Interval 5.9 to 10.6
|
2.9 Months
Interval 2.0 to 6.0
|
SECONDARY outcome
Timeframe: Up to approximately 75 monthsPopulation: All enrolled participants with a positive PD-L1 tumor status who received ≥1 dose of study drug.
PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. 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 progression. The PFS for only PD-L1 positive participants during first course pembrolizumab treatment per protocol, is presented. Note: All participants in Cohort 3 had a PD-L1-positive tumor status.
Outcome measures
| Measure |
Cohort 1: Pembrolizumab Monotherapy, Previously Treated
n=148 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
Cohort 2: Pembrolizumab Combination Therapy, Treatment Naive
n=15 Participants
Participants received pembrolizumab 200 mg IV each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m\^2 IV Q3W for up to 6 cycles + 5-Fluorouracil (5-FU) 800 mg/m\^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m\^2 orally, twice per day (BID) on Days 1-14 of each 3-week cycle. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
Cohort 3: Pembrolizumab Monotherapy, Treatment Naive, PD-L1 Positive
n=31 Participants
Programmed death-ligand 1 (PD-L1) positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
|---|---|---|---|
|
Progression-Free Survival For PD-L1 Positive Participants
|
2.1 Months
Interval 2.0 to 2.1
|
6.5 Months
Interval 4.7 to 7.9
|
2.9 Months
Interval 2.0 to 6.0
|
SECONDARY outcome
Timeframe: Up to approximately 75 monthsPopulation: All enrolled participants who received ≥1 dose of study drug.
Overall Survival (OS) was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. The OS for all participants (regardless of PD-L1 tumor status) during first course pembrolizumab treatment per protocol, is presented.
Outcome measures
| Measure |
Cohort 1: Pembrolizumab Monotherapy, Previously Treated
n=259 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
Cohort 2: Pembrolizumab Combination Therapy, Treatment Naive
n=25 Participants
Participants received pembrolizumab 200 mg IV each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m\^2 IV Q3W for up to 6 cycles + 5-Fluorouracil (5-FU) 800 mg/m\^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m\^2 orally, twice per day (BID) on Days 1-14 of each 3-week cycle. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
Cohort 3: Pembrolizumab Monotherapy, Treatment Naive, PD-L1 Positive
n=31 Participants
Programmed death-ligand 1 (PD-L1) positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
|---|---|---|---|
|
Overall Survival (OS) For All Participants
|
5.5 Months
Interval 4.2 to 6.7
|
13.8 Months
Interval 8.6 to 25.6
|
20.7 Months
Interval 10.0 to 29.8
|
SECONDARY outcome
Timeframe: Up to approximately 75 monthsPopulation: All enrolled participants with a positive PD-L1 tumor status who received ≥1 dose of study drug.
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. The OS for only PD-L1 positive participants during first course pembrolizumab treatment per protocol, is presented. Note: All participants in Cohort 3 had a PD-L1-positive tumor status.
Outcome measures
| Measure |
Cohort 1: Pembrolizumab Monotherapy, Previously Treated
n=148 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
Cohort 2: Pembrolizumab Combination Therapy, Treatment Naive
n=15 Participants
Participants received pembrolizumab 200 mg IV each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m\^2 IV Q3W for up to 6 cycles + 5-Fluorouracil (5-FU) 800 mg/m\^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m\^2 orally, twice per day (BID) on Days 1-14 of each 3-week cycle. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
Cohort 3: Pembrolizumab Monotherapy, Treatment Naive, PD-L1 Positive
n=31 Participants
Programmed death-ligand 1 (PD-L1) positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
|---|---|---|---|
|
Overall Survival For PD-L1 Positive Participants
|
5.8 Months
Interval 4.4 to 7.8
|
11.1 Months
Interval 5.4 to 22.3
|
20.7 Months
Interval 10.0 to 29.8
|
SECONDARY outcome
Timeframe: Up to approximately 75 monthsPopulation: All enrolled participants who received ≥1 dose of study drug.
Disease Control Rate (DCR) was defined as the percentage of participants in the analysis population who had a CR or a PR (CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions) or stable disease (SD); (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) for ≥6 months, (for Cohort 1 ≥2 months) as assessed by central radiology review. The percentage of all participants (regardless of PD-L1 tumor status) who had a CR or PR or SD during first course pembrolizumab treatment per protocol, is presented.
Outcome measures
| Measure |
Cohort 1: Pembrolizumab Monotherapy, Previously Treated
n=259 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
Cohort 2: Pembrolizumab Combination Therapy, Treatment Naive
n=25 Participants
Participants received pembrolizumab 200 mg IV each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m\^2 IV Q3W for up to 6 cycles + 5-Fluorouracil (5-FU) 800 mg/m\^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m\^2 orally, twice per day (BID) on Days 1-14 of each 3-week cycle. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
Cohort 3: Pembrolizumab Monotherapy, Treatment Naive, PD-L1 Positive
n=31 Participants
Programmed death-ligand 1 (PD-L1) positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
|---|---|---|---|
|
Disease Control Rate (DCR) For All Participants
|
27.0 Percentage of Participants
Interval 21.7 to 32.9
|
80.0 Percentage of Participants
Interval 59.3 to 93.2
|
32.3 Percentage of Participants
Interval 16.7 to 51.4
|
SECONDARY outcome
Timeframe: Up to approximately 75 monthsPopulation: All enrolled participants with a positive PD-L1 tumor status who received ≥1 dose of study drug.
DCR was defined as the percentage of participants in the analysis population who had a CR or a PR (CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions) or stable disease (SD); (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) for ≥6 months, (for Cohort 1 ≥2 months) as assessed by central radiology review. The percentage of participants with PD-L1+ tumor status who experienced a CR or PR or SD during first course pembrolizumab treatment per protocol, is presented. Note: All participants in Cohort 3 had a PD-L1-positive tumor status.
Outcome measures
| Measure |
Cohort 1: Pembrolizumab Monotherapy, Previously Treated
n=148 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
Cohort 2: Pembrolizumab Combination Therapy, Treatment Naive
n=15 Participants
Participants received pembrolizumab 200 mg IV each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m\^2 IV Q3W for up to 6 cycles + 5-Fluorouracil (5-FU) 800 mg/m\^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m\^2 orally, twice per day (BID) on Days 1-14 of each 3-week cycle. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
Cohort 3: Pembrolizumab Monotherapy, Treatment Naive, PD-L1 Positive
n=31 Participants
Programmed death-ligand 1 (PD-L1) positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months. Eligible participants allocated to the pembrolizumab first course, who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year.
|
|---|---|---|---|
|
Disease Control Rate For PD-L1 Positive Participants
|
33.1 Percentage of Participants
Interval 25.6 to 41.3
|
80.0 Percentage of Participants
Interval 51.9 to 95.7
|
32.3 Percentage of Participants
Interval 16.7 to 51.4
|
Adverse Events
Cohort 1 First Course
Serious events: 119 serious events
Other events: 237 other events
Deaths: 244 deaths
Cohort 2 First Course
Serious events: 11 serious events
Other events: 25 other events
Deaths: 21 deaths
Cohort 3 First Course
Serious events: 15 serious events
Other events: 31 other events
Deaths: 26 deaths
Cohort 1 Second Course
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Cohort 2 Second Course
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Cohort 3 Second Course
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cohort 1 First Course
n=259 participants at risk
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months.
|
Cohort 2 First Course
n=25 participants at risk
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m\^2 IV Q3W for up to 6 cycles + 5-FU 800 mg/m\^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m\^2 orally, BID on Days 1-14 of each 3-week cycle.
|
Cohort 3 First Course
n=31 participants at risk
PD-L1 positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months
|
Cohort 1 Second Course
n=3 participants at risk
Eligible participants allocated to the pembrolizumab first course in Cohort 1 who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg on Day 1 of each 3 week cycle (Q3W) for up to 17 cycles up to approximately an additional year.
|
Cohort 2 Second Course
n=1 participants at risk
Eligible participants allocated to the pembrolizumab first course in Cohort 2 who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg on Day 1 of each 3 week cycle (Q3W) for up to 17 cycles up to approximately an additional year.
|
Cohort 3 Second Course
n=2 participants at risk
Eligible participants allocated to the pembrolizumab first course in Cohort 3 who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg on Day 1 of each 3 week cycle (Q3W) for up to 17 cycles up to approximately an additional year.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Bacteraemia
|
0.00%
0/259 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.2%
1/31 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Clostridium difficile infection
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Blood and lymphatic system disorders
Abdominal lymphadenopathy
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
6/259 • Number of events 6 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Cardiac disorders
Atrial fibrillation
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Cardiac disorders
Cardiac arrest
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Cardiac disorders
Cardiac tamponade
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Cardiac disorders
Myocardial infarction
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Cardiac disorders
Pericardial effusion
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.77%
2/259 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Congenital, familial and genetic disorders
Tracheo-oesophageal fistula
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Endocrine disorders
Hypothyroidism
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Endocrine disorders
Thyroiditis
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Eye disorders
Diffuse uveal melanocytic proliferation
|
0.00%
0/259 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.2%
1/31 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
4/259 • Number of events 4 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
4.0%
1/25 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.2%
3/259 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Ascites
|
0.77%
2/259 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Colitis
|
0.77%
2/259 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.2%
1/31 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Constipation
|
1.2%
3/259 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
3/259 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.2%
1/31 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Dysphagia
|
2.7%
7/259 • Number of events 7 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
4.0%
1/25 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.2%
1/31 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Gastric stenosis
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.2%
3/259 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/259 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
4.0%
1/25 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Ileus
|
0.77%
2/259 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.3%
6/259 • Number of events 6 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Jejunal perforation
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Melaena
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Nausea
|
1.9%
5/259 • Number of events 7 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Oesophageal intramural haematoma
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Oesophageal perforation
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.77%
2/259 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.2%
1/31 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/259 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
16.0%
4/25 • Number of events 4 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
5/259 • Number of events 6 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
General disorders
Asthenia
|
1.5%
4/259 • Number of events 4 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
General disorders
Chest pain
|
0.00%
0/259 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.2%
1/31 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
General disorders
Death
|
0.77%
2/259 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
General disorders
Fatigue
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
General disorders
Gastrointestinal complication associated with device
|
0.00%
0/259 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
4.0%
1/25 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
General disorders
Influenza like illness
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/259 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.2%
1/31 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
General disorders
Non-cardiac chest pain
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
General disorders
Pyrexia
|
1.2%
3/259 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
4.0%
1/25 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/259 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.2%
1/31 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Hepatobiliary disorders
Cholangitis
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.2%
1/31 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
4.0%
1/25 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.2%
1/31 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.77%
2/259 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Hepatobiliary disorders
Hepatic haematoma
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Hepatobiliary disorders
Hepatitis
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Hepatobiliary disorders
Jaundice
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Abdominal abscess
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Disseminated varicella zoster virus infection
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Diverticulitis intestinal haemorrhagic
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Encephalitis
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Liver abscess
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Osteomyelitis
|
0.39%
1/259 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/259 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
4.0%
1/25 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/259 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
4.0%
1/25 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Pneumonia
|
1.5%
4/259 • Number of events 6 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
6.5%
2/31 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Pyelonephritis
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Sepsis
|
1.9%
5/259 • Number of events 5 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Septic shock
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Subdiaphragmatic abscess
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Urinary tract infection
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Wound infection
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Injury, poisoning and procedural complications
Anastomotic stenosis
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/259 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.2%
1/31 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/259 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.2%
1/31 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Aspartate aminotransferase increased
|
0.77%
2/259 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Blood bilirubin increased
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.2%
1/31 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Blood creatinine increased
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Transaminases increased
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Urine output decreased
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.0%
2/25 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
4/259 • Number of events 4 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.2%
1/31 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.77%
2/259 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.77%
2/259 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
5/259 • Number of events 5 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/259 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.2%
1/31 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/259 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
4.0%
1/25 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to adrenals
|
0.00%
0/259 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.2%
1/31 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal squamous cell carcinoma
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
1.2%
3/259 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/259 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
4.0%
1/25 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Nervous system disorders
Cauda equina syndrome
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Nervous system disorders
Dizziness
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Nervous system disorders
Dysarthria
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Nervous system disorders
Seizure
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
4.0%
1/25 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Nervous system disorders
Syncope
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.39%
1/259 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Nervous system disorders
Vertebral artery occlusion
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Psychiatric disorders
Anxiety
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Psychiatric disorders
Confusional state
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Psychiatric disorders
Delirium
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Psychiatric disorders
Depression
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Psychiatric disorders
Drug dependence
|
0.00%
0/259 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.2%
1/31 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.3%
6/259 • Number of events 6 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.2%
1/31 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/259 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
4.0%
1/25 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
3/259 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.77%
2/259 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.5%
9/259 • Number of events 9 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.2%
1/31 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.77%
2/259 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.2%
1/31 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.77%
2/259 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
6.5%
2/31 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.3%
6/259 • Number of events 6 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
6.5%
2/31 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.77%
2/259 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Skin and subcutaneous tissue disorders
Lichen planus
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/259 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
4.0%
1/25 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/259 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.0%
2/25 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/259 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.2%
1/31 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Vascular disorders
Embolism
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
4.0%
1/25 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Vascular disorders
Haematoma
|
0.00%
0/259 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.2%
1/31 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Vascular disorders
Internal haemorrhage
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Vascular disorders
Vena cava thrombosis
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
Other adverse events
| Measure |
Cohort 1 First Course
n=259 participants at risk
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months.
|
Cohort 2 First Course
n=25 participants at risk
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 40 months + cisplatin 80 mg/m\^2 IV Q3W for up to 6 cycles + 5-FU 800 mg/m\^2 IV on Days 1-5 every 3 weeks or (Japan only) capecitabine 1000 mg/m\^2 orally, BID on Days 1-14 of each 3-week cycle.
|
Cohort 3 First Course
n=31 participants at risk
PD-L1 positive participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle (Q3W) for up to 52 months
|
Cohort 1 Second Course
n=3 participants at risk
Eligible participants allocated to the pembrolizumab first course in Cohort 1 who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg on Day 1 of each 3 week cycle (Q3W) for up to 17 cycles up to approximately an additional year.
|
Cohort 2 Second Course
n=1 participants at risk
Eligible participants allocated to the pembrolizumab first course in Cohort 2 who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg on Day 1 of each 3 week cycle (Q3W) for up to 17 cycles up to approximately an additional year.
|
Cohort 3 Second Course
n=2 participants at risk
Eligible participants allocated to the pembrolizumab first course in Cohort 3 who stopped pembrolizumab with SD or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg on Day 1 of each 3 week cycle (Q3W) for up to 17 cycles up to approximately an additional year.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
4.6%
12/259 • Number of events 13 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
20.0%
5/25 • Number of events 5 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
9.7%
3/31 • Number of events 6 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Nervous system disorders
Neuropathy peripheral
|
1.2%
3/259 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
12.0%
3/25 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.2%
1/31 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.9%
5/259 • Number of events 5 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
24.0%
6/25 • Number of events 7 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Nervous system disorders
Syncope
|
0.77%
2/259 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.0%
2/25 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Psychiatric disorders
Anxiety
|
5.8%
15/259 • Number of events 18 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.2%
1/31 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Psychiatric disorders
Insomnia
|
6.6%
17/259 • Number of events 20 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
36.0%
9/25 • Number of events 9 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
6.5%
2/31 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.0%
44/259 • Number of events 50 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.0%
2/25 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
19.4%
6/31 • Number of events 8 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.4%
40/259 • Number of events 43 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
4.0%
1/25 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
16.1%
5/31 • Number of events 7 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.2%
3/259 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.0%
2/25 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.5%
4/259 • Number of events 4 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
32.0%
8/25 • Number of events 16 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.1%
8/259 • Number of events 8 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.0%
2/25 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.2%
11/259 • Number of events 14 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.0%
2/25 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
6.5%
2/31 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.77%
2/259 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
4.0%
1/25 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
9.7%
3/31 • Number of events 4 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.2%
3/259 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
16.0%
4/25 • Number of events 4 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
6.5%
2/31 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.6%
17/259 • Number of events 18 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.0%
2/25 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
9.7%
3/31 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
12.0%
3/25 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.7%
33/259 • Number of events 39 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
16.0%
4/25 • Number of events 7 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
25.8%
8/31 • Number of events 10 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.0%
31/259 • Number of events 33 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.0%
2/25 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
9.7%
3/31 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.9%
5/259 • Number of events 5 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
4.0%
1/25 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
6.5%
2/31 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.0%
2/25 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.2%
1/31 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
1.2%
3/259 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
6.5%
2/31 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
6.5%
2/31 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Vascular disorders
Hypertension
|
5.4%
14/259 • Number of events 20 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
4.0%
1/25 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Vascular disorders
Hypotension
|
3.9%
10/259 • Number of events 12 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
6.5%
2/31 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/259 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.0%
2/25 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Ascites
|
6.2%
16/259 • Number of events 18 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.2%
1/31 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Blood and lymphatic system disorders
Anaemia
|
22.4%
58/259 • Number of events 69 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
44.0%
11/25 • Number of events 13 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
22.6%
7/31 • Number of events 9 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.5%
4/259 • Number of events 7 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.0%
2/25 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.2%
3/259 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
36.0%
9/25 • Number of events 12 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.2%
1/31 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.1%
8/259 • Number of events 10 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
12.0%
3/25 • Number of events 5 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.2%
1/31 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/259 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
16.0%
4/25 • Number of events 4 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Endocrine disorders
Hyperthyroidism
|
3.9%
10/259 • Number of events 10 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
16.0%
4/25 • Number of events 4 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
6.5%
2/31 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Endocrine disorders
Hypothyroidism
|
9.3%
24/259 • Number of events 24 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.0%
2/25 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
6.5%
2/31 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.77%
2/259 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.0%
2/25 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.2%
1/31 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.8%
15/259 • Number of events 15 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.0%
2/25 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
6.5%
2/31 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Abdominal pain
|
18.9%
49/259 • Number of events 56 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
12.0%
3/25 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
25.8%
8/31 • Number of events 13 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.3%
19/259 • Number of events 25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
16.0%
4/25 • Number of events 8 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
6.5%
2/31 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Constipation
|
20.1%
52/259 • Number of events 57 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
56.0%
14/25 • Number of events 22 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
22.6%
7/31 • Number of events 7 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Diarrhoea
|
17.8%
46/259 • Number of events 55 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
56.0%
14/25 • Number of events 18 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
25.8%
8/31 • Number of events 13 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Dry mouth
|
3.1%
8/259 • Number of events 8 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.0%
2/25 • Number of events 4 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
9.7%
3/31 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.5%
9/259 • Number of events 9 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.0%
2/25 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
9.7%
3/31 • Number of events 4 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Dysphagia
|
12.0%
31/259 • Number of events 36 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
4.0%
1/25 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.9%
10/259 • Number of events 12 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.0%
2/25 • Number of events 4 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
6.5%
2/31 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Nausea
|
25.1%
65/259 • Number of events 74 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
60.0%
15/25 • Number of events 22 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
25.8%
8/31 • Number of events 10 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Stomatitis
|
3.9%
10/259 • Number of events 10 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
68.0%
17/25 • Number of events 29 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.2%
1/31 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Vomiting
|
13.9%
36/259 • Number of events 44 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
40.0%
10/25 • Number of events 23 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
19.4%
6/31 • Number of events 12 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
General disorders
Asthenia
|
9.3%
24/259 • Number of events 26 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
16.0%
4/25 • Number of events 7 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
6.5%
2/31 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
General disorders
Chest discomfort
|
0.77%
2/259 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
6.5%
2/31 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
General disorders
Fatigue
|
35.9%
93/259 • Number of events 105 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
40.0%
10/25 • Number of events 13 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
32.3%
10/31 • Number of events 10 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
General disorders
Generalised oedema
|
0.00%
0/259 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
6.5%
2/31 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
General disorders
Influenza like illness
|
1.5%
4/259 • Number of events 5 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
12.9%
4/31 • Number of events 5 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
General disorders
Malaise
|
2.7%
7/259 • Number of events 7 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
20.0%
5/25 • Number of events 14 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
General disorders
Mucosal inflammation
|
0.39%
1/259 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.0%
2/25 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Alanine aminotransferase increased
|
5.4%
14/259 • Number of events 19 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.0%
2/25 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
6.5%
2/31 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
General disorders
Oedema
|
3.5%
9/259 • Number of events 9 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
16.0%
4/25 • Number of events 10 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
General disorders
Oedema peripheral
|
16.6%
43/259 • Number of events 57 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
4.0%
1/25 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
12.9%
4/31 • Number of events 6 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
General disorders
Pyrexia
|
9.7%
25/259 • Number of events 35 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
24.0%
6/25 • Number of events 9 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
9.7%
3/31 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Nasopharyngitis
|
2.7%
7/259 • Number of events 8 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.0%
2/25 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Pneumonia
|
3.1%
8/259 • Number of events 10 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.0%
2/25 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.2%
1/31 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Aspartate aminotransferase increased
|
11.6%
30/259 • Number of events 34 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.0%
2/25 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
12.9%
4/31 • Number of events 6 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Blood alkaline phosphatase increased
|
12.0%
31/259 • Number of events 32 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
4.0%
1/25 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.2%
1/31 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Blood creatinine increased
|
5.0%
13/259 • Number of events 15 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
20.0%
5/25 • Number of events 6 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
6.5%
2/31 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.7%
7/259 • Number of events 9 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.0%
2/25 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Haemoglobin decreased
|
1.5%
4/259 • Number of events 4 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
6.5%
2/31 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Lymphocyte count decreased
|
2.3%
6/259 • Number of events 8 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
6.5%
2/31 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Neutrophil count decreased
|
0.77%
2/259 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
52.0%
13/25 • Number of events 30 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.2%
1/31 • Number of events 6 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Weight increased
|
0.77%
2/259 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
12.0%
3/25 • Number of events 13 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Platelet count decreased
|
1.2%
3/259 • Number of events 4 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
20.0%
5/25 • Number of events 7 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Weight decreased
|
14.7%
38/259 • Number of events 41 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
20.0%
5/25 • Number of events 6 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
12.9%
4/31 • Number of events 4 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
White blood cell count decreased
|
0.77%
2/259 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
16.0%
4/25 • Number of events 9 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
28.2%
73/259 • Number of events 81 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
52.0%
13/25 • Number of events 22 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
35.5%
11/31 • Number of events 14 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.8%
15/259 • Number of events 20 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.0%
2/25 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
6.5%
2/31 • Number of events 4 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/259 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.0%
2/25 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.9%
23/259 • Number of events 29 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
12.0%
3/25 • Number of events 6 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
6.5%
2/31 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
9.3%
24/259 • Number of events 24 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
4.0%
1/25 • Number of events 1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
12.9%
4/31 • Number of events 4 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.6%
12/259 • Number of events 13 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
12.0%
3/25 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.77%
2/259 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.0%
2/25 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.9%
23/259 • Number of events 26 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
4.0%
1/25 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
9.7%
3/31 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.9%
10/259 • Number of events 14 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.0%
2/25 • Number of events 4 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/31 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.9%
36/259 • Number of events 58 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
12.0%
3/25 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
16.1%
5/31 • Number of events 8 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.1%
34/259 • Number of events 38 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.0%
2/25 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
19.4%
6/31 • Number of events 7 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.9%
5/259 • Number of events 5 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
6.5%
2/31 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
1.2%
3/259 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
9.7%
3/31 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.2%
3/259 • Number of events 3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
6.5%
2/31 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.1%
8/259 • Number of events 10 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.0%
2/25 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
16.1%
5/31 • Number of events 7 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.5%
9/259 • Number of events 12 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/25 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
16.1%
5/31 • Number of events 6 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Nervous system disorders
Dizziness
|
6.6%
17/259 • Number of events 17 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
16.0%
4/25 • Number of events 5 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
12.9%
4/31 • Number of events 6 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Nervous system disorders
Dysgeusia
|
2.3%
6/259 • Number of events 6 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
24.0%
6/25 • Number of events 9 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
6.5%
2/31 • Number of events 2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/3 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/1 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/2 • Up to approximately 75 months
The population analyzed for all-cause mortality consisted of all allocated participants. The population for AEs consisted of all allocated participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Therefore the following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
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 must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
- Publication restrictions are in place
Restriction type: OTHER