Trial Outcomes & Findings for Study of Pembrolizumab (MK-3475) as First-Line Monotherapy and Combination Therapy for Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-062/KEYNOTE-062) (NCT NCT02494583)
NCT ID: NCT02494583
Last Updated: 2023-04-13
Results Overview
PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Per protocol, PFS in the pembro combo arm was compared to the SOC arm as a pre-specified primary analysis of the Intent-To-Treat (ITT) population. PFS is reported here for all participants in the pembro combo arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, PFS was compared separately between CPS ≥1 participants of the pembro mono arm and SOC arm and is presented later in the record.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
763 participants
Primary outcome timeframe
Up to approximately 36 months
Results posted on
2023-04-13
Participant Flow
Participants with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who were programmed death-ligand 1 (PD-L1)-positive (Combined Positive Score \[CPS\]≥1) and human epidermal growth factor receptor 2 (HER2/neu)-negative were recruited to the study.
Of 1,787 screened, 763 were randomized 1:1:1 to the pembrolizumab monotherapy (pembro mono) arm, pembrolizumab plus standard of care (SOC) chemotherapy (pembro combo) arm, or placebo plus SOC chemotherapy (SOC) arm. Per protocol, response/progression or adverse events (AEs) that occurred during the second course were not counted towards efficacy outcome measures or safety outcome measures, respectively.
Participant milestones
| Measure |
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W). Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
|
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-fluorouracil (5-FU) 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
|
Placebo + SOC Chemotherapy (SOC)
Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
|---|---|---|---|
|
Overall Study
STARTED
|
256
|
257
|
250
|
|
Overall Study
Received First Course of Pembrolizumab
|
254
|
250
|
244
|
|
Overall Study
Received Second Course of Pembrolizumab
|
4
|
5
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
256
|
257
|
250
|
Reasons for withdrawal
| Measure |
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W). Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
|
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-fluorouracil (5-FU) 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
|
Placebo + SOC Chemotherapy (SOC)
Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
|---|---|---|---|
|
Overall Study
Death
|
224
|
214
|
225
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
2
|
0
|
|
Overall Study
Screen Failure
|
0
|
1
|
0
|
|
Overall Study
Transferred to Extension Study
|
15
|
15
|
6
|
|
Overall Study
Did Not Continue on Extension Study
|
8
|
10
|
4
|
|
Overall Study
Withdrawal by Subject
|
7
|
15
|
15
|
Baseline Characteristics
Study of Pembrolizumab (MK-3475) as First-Line Monotherapy and Combination Therapy for Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-062/KEYNOTE-062)
Baseline characteristics by cohort
| Measure |
Pembrolizumab Monotherapy (Pembro Mono)
n=256 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W). Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
|
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
n=257 Participants
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-fluorouracil (5-FU) 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
|
Placebo + SOC Chemotherapy (SOC)
n=250 Participants
Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
Total
n=763 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.9 Years
STANDARD_DEVIATION 11.6 • n=39 Participants
|
60.9 Years
STANDARD_DEVIATION 11.6 • n=41 Participants
|
60.7 Years
STANDARD_DEVIATION 12.7 • n=35 Participants
|
60.5 Years
STANDARD_DEVIATION 12.0 • n=31 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=39 Participants
|
62 Participants
n=41 Participants
|
71 Participants
n=35 Participants
|
209 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
180 Participants
n=39 Participants
|
195 Participants
n=41 Participants
|
179 Participants
n=35 Participants
|
554 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
45 Participants
n=39 Participants
|
54 Participants
n=41 Participants
|
46 Participants
n=35 Participants
|
145 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
206 Participants
n=39 Participants
|
196 Participants
n=41 Participants
|
197 Participants
n=35 Participants
|
599 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
19 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
9 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
29 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
69 Participants
n=39 Participants
|
71 Participants
n=41 Participants
|
67 Participants
n=35 Participants
|
207 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
13 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
164 Participants
n=39 Participants
|
167 Participants
n=41 Participants
|
154 Participants
n=35 Participants
|
485 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
22 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
|
Region of Enrollment
Europe/North America/Australia
|
148 Participants
n=39 Participants
|
148 Participants
n=41 Participants
|
147 Participants
n=35 Participants
|
443 Participants
n=31 Participants
|
|
Region of Enrollment
Asia
|
62 Participants
n=39 Participants
|
64 Participants
n=41 Participants
|
61 Participants
n=35 Participants
|
187 Participants
n=31 Participants
|
|
Region of Enrollment
Rest of the World
|
46 Participants
n=39 Participants
|
45 Participants
n=41 Participants
|
42 Participants
n=35 Participants
|
133 Participants
n=31 Participants
|
|
Disease Status
Locally advanced
|
10 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
35 Participants
n=31 Participants
|
|
Disease Status
Metastatic
|
245 Participants
n=39 Participants
|
243 Participants
n=41 Participants
|
235 Participants
n=35 Participants
|
723 Participants
n=31 Participants
|
|
Disease Status
Missing
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
|
Fluoropyrimidine Treatment
5-FU
|
97 Participants
n=39 Participants
|
98 Participants
n=41 Participants
|
95 Participants
n=35 Participants
|
290 Participants
n=31 Participants
|
|
Fluoropyrimidine Treatment
Capecitabine
|
159 Participants
n=39 Participants
|
159 Participants
n=41 Participants
|
155 Participants
n=35 Participants
|
473 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 36 monthsPopulation: All CPS ≥1 participants in the ITT population randomized to the pembro combo arm and SOC arm were analyzed. Per protocol, the pembro mono arm was compared to the SOC arm separately and not included in this analysis.
PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Per protocol, PFS in the pembro combo arm was compared to the SOC arm as a pre-specified primary analysis of the Intent-To-Treat (ITT) population. PFS is reported here for all participants in the pembro combo arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, PFS was compared separately between CPS ≥1 participants of the pembro mono arm and SOC arm and is presented later in the record.
Outcome measures
| Measure |
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg IV Q3W.
|
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
n=257 Participants
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
Placebo + SOC Chemotherapy (SOC)
n=250 Participants
Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
|---|---|---|---|
|
Pembro Combo vs SOC: Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With PD-L1 CPS ≥1 (All Participants)
|
—
|
6.9 Months
Interval 5.7 to 7.3
|
6.4 Months
Interval 5.7 to 7.0
|
PRIMARY outcome
Timeframe: Up to approximately 42 monthsPopulation: All CPS ≥1 participants in the ITT population randomized to the pembro combo arm and SOC arm were analyzed. Per protocol, the pembro mono arm was compared to the SOC arm separately and not included in this analysis.
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. Per protocol, OS in the pembro combo arm was compared to the SOC arm as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro combo arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, OS was compared separately between CPS ≥1 participants of the pembro mono arm and SOC arm and is presented later in the record.
Outcome measures
| Measure |
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg IV Q3W.
|
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
n=257 Participants
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
Placebo + SOC Chemotherapy (SOC)
n=250 Participants
Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
|---|---|---|---|
|
Pembro Combo vs SOC: Overall Survival (OS) in Participants With PD-L1 CPS ≥1 (All Participants)
|
—
|
12.5 Months
Interval 10.8 to 13.9
|
11.1 Months
Interval 9.2 to 12.8
|
PRIMARY outcome
Timeframe: Up to approximately 42 monthsPopulation: All CPS ≥10 participants in the ITT population randomized to the pembro combo arm and SOC arm were analyzed. Per protocol, the pembro mono arm was compared to the SOC arm separately and not included in this analysis.
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. Per protocol, OS in the pembro combo arm was compared to the SOC arm as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro combo arm and SOC arm who were PD-L1 CPS ≥10. Per protocol, OS was compared separately between CPS ≥10 participants of the pembro mono arm and SOC arm and is presented later in the record.
Outcome measures
| Measure |
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg IV Q3W.
|
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
n=99 Participants
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
Placebo + SOC Chemotherapy (SOC)
n=90 Participants
Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
|---|---|---|---|
|
Pembro Combo vs SOC: OS in Participants With PD-L1 CPS ≥10
|
—
|
12.3 Months
Interval 9.5 to 14.8
|
10.8 Months
Interval 8.5 to 13.8
|
PRIMARY outcome
Timeframe: Up to approximately 42 monthsPopulation: All CPS ≥1 participants in the ITT population randomized to the pembro mono arm and SOC arm were analyzed. Per protocol, the pembro combo arm was compared to the SOC arm separately and not included in this analysis.
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. Per protocol, OS in the pembro mono arm was compared to the SOC arm as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, OS was compared separately between CPS ≥1 participants of the pembro combo arm and SOC arm and is presented earlier in the record.
Outcome measures
| Measure |
Pembrolizumab Monotherapy (Pembro Mono)
n=256 Participants
Participants received pembrolizumab 200 mg IV Q3W.
|
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
Placebo + SOC Chemotherapy (SOC)
n=250 Participants
Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
|---|---|---|---|
|
Pembro Mono vs SOC: OS in Participants With PD-L1 CPS ≥1 (All Participants)
|
10.6 Months
Interval 7.7 to 13.8
|
—
|
11.1 Months
Interval 9.2 to 12.8
|
PRIMARY outcome
Timeframe: Up to approximately 42 monthsPopulation: All CPS ≥10 participants in the ITT population randomized to the pembro mono arm and SOC arm were analyzed. Per protocol, the pembro combo arm was compared to the SOC arm separately and not included in this analysis.
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. Per protocol, OS in the pembro mono arm was compared to the SOC arm as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥10. Per protocol, OS was compared separately between CPS ≥10 participants of the pembro combo arm and SOC arm and is presented earlier in the record.
Outcome measures
| Measure |
Pembrolizumab Monotherapy (Pembro Mono)
n=92 Participants
Participants received pembrolizumab 200 mg IV Q3W.
|
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
Placebo + SOC Chemotherapy (SOC)
n=90 Participants
Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
|---|---|---|---|
|
Pembro Mono vs SOC: OS in Participants With PD-L1 CPS ≥10
|
17.4 Months
Interval 9.1 to 23.1
|
—
|
10.8 Months
Interval 8.5 to 13.8
|
SECONDARY outcome
Timeframe: Up to approximately 42 monthsPopulation: All CPS ≥1 participants in the ITT population randomized to the pembro combo arm and SOC arm were analyzed. Per protocol, the pembro mono arm was compared to the SOC arm separately and not included in this analysis.
ORR was defined as the percentage of participants in the analysis population who have a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. Per protocol, ORR in the pembro combo arm was compared to the SOC arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced CR or PR is reported here as the ORR for all participants in the pembro combo arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, ORR was compared separately between CPS ≥1 participants of the pembro mono arm and SOC arm and is presented later in the record.
Outcome measures
| Measure |
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg IV Q3W.
|
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
n=257 Participants
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
Placebo + SOC Chemotherapy (SOC)
n=250 Participants
Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
|---|---|---|---|
|
Pembro Combo vs SOC: Objective Response Rate (ORR) Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants)
|
—
|
48.6 Percentage of Participants
Interval 42.4 to 54.9
|
37.2 Percentage of Participants
Interval 31.2 to 43.5
|
SECONDARY outcome
Timeframe: Up to approximately 42 monthsPopulation: All CPS ≥1 participants in the ITT population randomized to the pembro combo arm and SOC arm and who demonstrated a confirmed CR or PR were analyzed. Per protocol, the pembro mono arm was compared to the SOC arm separately and not included in this analysis.
For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 based upon BICR, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. DOR is reported here for all participants in the pembro combo arm and SOC arm who were PD-L1 CPS ≥1 (all participants) and had CR or PR. Per protocol, DOR was compared separately between CPS ≥1 responders of the pembro mono arm and SOC arm and is presented later in the record.
Outcome measures
| Measure |
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg IV Q3W.
|
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
n=125 Participants
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
Placebo + SOC Chemotherapy (SOC)
n=93 Participants
Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
|---|---|---|---|
|
Pembro Combo vs SOC: Duration of Response (DOR) Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants)
|
—
|
NA Months
NA=Median DOR and DOR range lower and upper limit not reached (no progressive disease by time of last disease assessment)
|
NA Months
NA=Median DOR and DOR range lower and upper limit not reached (no progressive disease by time of last disease assessment)
|
SECONDARY outcome
Timeframe: Up to approximately 42 monthsPopulation: All CPS ≥1 participants in the ITT population randomized to the pembro mono arm and SOC arm were analyzed. Per protocol, the pembro combo arm was compared to the SOC arm separately and not included in this analysis.
ORR was defined as the percentage of participants in the analysis population who have a CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. Per protocol, ORR in the pembro mono arm was compared to the SOC arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced CR or PR is reported here as the ORR for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, ORR was compared separately between CPS ≥1 participants of the pembro combo arm and SOC arm and is presented earlier in the record.
Outcome measures
| Measure |
Pembrolizumab Monotherapy (Pembro Mono)
n=256 Participants
Participants received pembrolizumab 200 mg IV Q3W.
|
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
Placebo + SOC Chemotherapy (SOC)
n=250 Participants
Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
|---|---|---|---|
|
Pembro Mono vs SOC: ORR Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants)
|
14.8 Percentage of Participants
Interval 10.7 to 19.8
|
—
|
37.2 Percentage of Participants
Interval 31.2 to 43.5
|
SECONDARY outcome
Timeframe: Up to approximately 42 monthsPopulation: All CPS ≥1 participants in the ITT population randomized to the pembro mono arm and SOC arm and who demonstrated a confirmed CR or PR were analyzed. Per protocol, the pembro combo arm was compared to the SOC arm separately and not included in this analysis.
For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 based upon BICR, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. DOR is reported here for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥1 (all participants) and had CR or PR. Per protocol, DOR was compared separately between CPS ≥1 responders of the pembro combo arm and SOC arm and is presented earlier in the record.
Outcome measures
| Measure |
Pembrolizumab Monotherapy (Pembro Mono)
n=38 Participants
Participants received pembrolizumab 200 mg IV Q3W.
|
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
Placebo + SOC Chemotherapy (SOC)
n=93 Participants
Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
|---|---|---|---|
|
Pembro Mono vs SOC: DOR Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants)
|
NA Months
NA=Median DOR and DOR range lower and upper limit not reached (no progressive disease by time of last disease assessment)
|
—
|
NA Months
NA=Median DOR and DOR range lower and upper limit not reached (no progressive disease by time of last disease assessment)
|
SECONDARY outcome
Timeframe: Up to approximately 42 monthsPopulation: All CPS ≥1 participants in the ITT population randomized to the pembro mono arm and SOC arm were analyzed. Per protocol, the pembro combo arm was compared to the SOC arm separately and not included in this analysis.
PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Per protocol, PFS in the pembro mono arm was compared to the SOC arm as a pre-specified secondary analysis of the ITT population. PFS is reported here for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, PFS was compared separately between CPS ≥1 participants of the pembro combo arm and SOC arm and is presented earlier in the record.
Outcome measures
| Measure |
Pembrolizumab Monotherapy (Pembro Mono)
n=256 Participants
Participants received pembrolizumab 200 mg IV Q3W.
|
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
Placebo + SOC Chemotherapy (SOC)
n=250 Participants
Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
|---|---|---|---|
|
Pembro Mono vs SOC: PFS Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants)
|
2.0 Months
Interval 1.5 to 2.8
|
—
|
6.4 Months
Interval 5.7 to 7.1
|
SECONDARY outcome
Timeframe: Baseline, Week 18Population: Participants in the pembro mono arm and SOC arm who received ≥1 dose of study drug and who had EORTC-QLQ-C30 assessments available at baseline or post-baseline up to Week 18. Per protocol, the pembro combo arm was compared to the SOC arm separately and not included in this analysis.
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared between all participants of the pembro mono arm and the SOC arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared separately between all participants of the pembro combo arm and SOC arm and is presented later in the record.
Outcome measures
| Measure |
Pembrolizumab Monotherapy (Pembro Mono)
n=251 Participants
Participants received pembrolizumab 200 mg IV Q3W.
|
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
Placebo + SOC Chemotherapy (SOC)
n=243 Participants
Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
|---|---|---|---|
|
Pembro Mono vs SOC: Change From Baseline to Week 18 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score
|
-1.91 Score on a Scale
Interval -5.81 to 1.98
|
—
|
-1.75 Score on a Scale
Interval -5.17 to 1.66
|
SECONDARY outcome
Timeframe: Baseline, Week 18Population: Participants in the pembro combo arm and SOC arm who received ≥1 dose of study drug and who had EORTC-QLQ-C30 assessments available at baseline or post-baseline up to Week 18. Per protocol, the pembro mono arm was compared to the SOC arm separately and not included in this analysis.
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the GHS question "How would you rate your overall health during the past week?" (Item 29) and the QoL question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared between all participants of the pembro combo arm and the SOC arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared separately between all participants of the pembro mono arm and SOC arm and is presented earlier in the record.
Outcome measures
| Measure |
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg IV Q3W.
|
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
n=245 Participants
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
Placebo + SOC Chemotherapy (SOC)
n=243 Participants
Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
|---|---|---|---|
|
Pembro Combo vs SOC: Change From Baseline to Week 18 in the EORTC QLQ-C30 Global Health Status/Quality of Life (Items 29 and 30) Combined Score
|
—
|
-0.09 Score on a Scale
Interval -3.36 to 3.19
|
-2.07 Score on a Scale
Interval -5.43 to 1.29
|
SECONDARY outcome
Timeframe: Baseline, Week 18Population: Participants in the pembro mono arm and SOC arm who received ≥1 dose of study drug and who had EORTC-QLQ-STO22 assessments available at baseline or post-baseline up to Week 18. Per protocol, the pembro combo arm was compared to the SOC arm separately and not included in this analysis.
EORTC-QLQ-STO22 is a 22-item questionnaire developed to assess QoL of gastric cancer participants. It consists of 5 multi-item subscales that assess dysphagia (3 items), dietary restriction (4 items), pain (4 items), upper gastro-esophageal symptoms (3 items), and emotional problems (3 items), and questions on dry mouth, taste, body image, and hair loss. Participant responses to the Pain symptom subscale (Items 34-37) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating more problems. Per protocol, change from baseline to Week 18 in the EORTC-QLQ-STO22 Pain score was compared between the pembro mono arm and the SOC arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 18 in the EORTC-QLQ-STO22 Pain score was compared separately between the pembro combo arm and SOC arm and is presented later in the record.
Outcome measures
| Measure |
Pembrolizumab Monotherapy (Pembro Mono)
n=251 Participants
Participants received pembrolizumab 200 mg IV Q3W.
|
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
Placebo + SOC Chemotherapy (SOC)
n=243 Participants
Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
|---|---|---|---|
|
Pembro Mono vs. SOC: Change From Baseline to Week 18 in EORTC QLQ-Module for Gastric Cancer (STO22) Pain Symptom Subscale Score
|
-1.14 Score on a Scale
Interval -4.67 to 2.39
|
—
|
-3.49 Score on a Scale
Interval -6.6 to -0.38
|
SECONDARY outcome
Timeframe: Baseline, Week 18Population: Participants in the pembro combo arm and SOC arm who received ≥1 dose of study drug and who had EORTC-QLQ-STO22 assessments available at baseline or post-baseline up to Week 18. Per protocol, the pembro mono arm was compared to the SOC arm separately and not included in this analysis.
EORTC-QLQ-STO22 is a 22-item questionnaire developed to assess QoL of gastric cancer participants. It consists of 5 multi-item subscales that assess dysphagia (3 items), dietary restriction (4 items), pain (4 items), upper gastro-esophageal symptoms (3 items), and emotional problems (3 items), and questions on dry mouth, taste, body image, and hair loss. Participant responses to the Pain symptom subscale (Items 34-37) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating more problems. Per protocol, change from baseline to Week 18 in the EORTC-QLQ-STO22 Pain score was compared between the pembro combo arm and the SOC arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 18 in the EORTC-QLQ-STO22 Pain score was compared separately between the pembro mono arm and SOC arm and is presented earlier in the record.
Outcome measures
| Measure |
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg IV Q3W.
|
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
n=245 Participants
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
Placebo + SOC Chemotherapy (SOC)
n=243 Participants
Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
|---|---|---|---|
|
Pembro Combo vs. SOC: Change From Baseline to Week 18 in EORTC QLQ-STO22 Pain Symptom Subscale Score
|
—
|
-10.12 Score on a Scale
Interval -13.08 to -7.17
|
-3.56 Score on a Scale
Interval -6.61 to -0.51
|
SECONDARY outcome
Timeframe: Up to approximately 33 monthsPopulation: All randomized participants who received at least 1 dose of trial treatment were analyzed.
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an adverse event. The number of participants who experienced an AE was reported for each arm according to the treatment received.
Outcome measures
| Measure |
Pembrolizumab Monotherapy (Pembro Mono)
n=254 Participants
Participants received pembrolizumab 200 mg IV Q3W.
|
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
n=250 Participants
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
Placebo + SOC Chemotherapy (SOC)
n=244 Participants
Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
|---|---|---|---|
|
Number of Participants Experiencing an Adverse Event (AE)
|
242 Participants
|
244 Participants
|
240 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 30 monthsPopulation: All randomized participants who received at least 1 dose of trial treatment were analyzed.
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an adverse event. The number of participants who discontinued study treatment due to an AE was reported for each arm according to the treatment received.
Outcome measures
| Measure |
Pembrolizumab Monotherapy (Pembro Mono)
n=254 Participants
Participants received pembrolizumab 200 mg IV Q3W.
|
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
n=250 Participants
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
Placebo + SOC Chemotherapy (SOC)
n=244 Participants
Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
|---|---|---|---|
|
Number of Participants Discontinuing Study Treatment Due to an AE
|
29 Participants
|
85 Participants
|
58 Participants
|
Adverse Events
Pembrolizumab Monotherapy (Pembro Mono) First Course
Serious events: 93 serious events
Other events: 216 other events
Deaths: 229 deaths
Pembrolizumab + SOC Chemotherapy (Pembro Combo)-First Course
Serious events: 122 serious events
Other events: 239 other events
Deaths: 232 deaths
Placebo + SOC Chemotherapy (SOC)-First Course
Serious events: 117 serious events
Other events: 234 other events
Deaths: 240 deaths
Pembrolizumab Monotherapy Second Course
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Pembrolizumab + SOC Chemotherapy-Second Course
Serious events: 0 serious events
Other events: 5 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Pembrolizumab Monotherapy (Pembro Mono) First Course
n=254 participants at risk
Participants received pembrolizumab 200 mg IV Q3W.
|
Pembrolizumab + SOC Chemotherapy (Pembro Combo)-First Course
n=250 participants at risk
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
Placebo + SOC Chemotherapy (SOC)-First Course
n=244 participants at risk
Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
Pembrolizumab Monotherapy Second Course
n=4 participants at risk
Eligible participants who stopped the initial course of pembrolizumab (200 mg IV Q3W for up to 35 treatments \[approximately 2 years\]) with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (up to approximately 1 additional year).
|
Pembrolizumab + SOC Chemotherapy-Second Course
n=5 participants at risk
Eligible participants who stopped the initial course of pembrolizumab (200 mg IV Q3W for up to 35 treatments \[approximately 2 years\]) administered in combination with SOC chemotherapy, and experienced Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (up to approximately 1 additional year).
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
3/254 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
4.8%
12/250 • Number of events 14 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
4.1%
10/244 • Number of events 13 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
3.6%
9/250 • Number of events 9 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.9%
7/244 • Number of events 8 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.2%
3/250 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.80%
2/250 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.2%
3/244 • Number of events 4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Cardiac arrest
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Cardiac failure
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Extrasystoles
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Pericardial effusion
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Addison's disease
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Hypophysitis
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.2%
3/250 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.82%
2/244 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Ascites
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.6%
4/250 • Number of events 5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.82%
2/244 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Colitis
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.4%
6/250 • Number of events 6 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Constipation
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.80%
2/250 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.8%
7/250 • Number of events 7 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
3.7%
9/244 • Number of events 9 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Dysphagia
|
0.79%
2/254 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.2%
3/250 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.0%
5/244 • Number of events 6 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.79%
2/254 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
2.0%
5/254 • Number of events 6 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.79%
2/254 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.2%
3/244 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Ileus
|
1.2%
3/254 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Incarcerated hiatus hernia
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.0%
5/250 • Number of events 7 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.0%
5/244 • Number of events 5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.79%
2/254 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.80%
2/250 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.2%
3/244 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.80%
2/250 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Peritoneocutaneous fistula
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.39%
1/254 • Number of events 4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.82%
2/244 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.80%
2/250 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.2%
3/244 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.2%
3/254 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.80%
2/250 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.82%
2/244 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
3/254 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.4%
6/250 • Number of events 7 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
4.9%
12/244 • Number of events 15 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Asthenia
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.2%
3/250 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.82%
2/244 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Chest pain
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Death
|
2.4%
6/254 • Number of events 6 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.2%
3/250 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Fatigue
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.2%
3/250 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
General physical health deterioration
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Malaise
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.80%
2/250 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.2%
3/244 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.79%
2/254 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Oedema peripheral
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Pain
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Peripheral swelling
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Pyrexia
|
0.79%
2/254 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.0%
5/250 • Number of events 5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.0%
5/244 • Number of events 6 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.80%
2/250 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Cholangitis
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Hepatitis
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Jaundice
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Liver disorder
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Abdominal sepsis
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Amoebiasis
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Biliary tract infection
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Candida sepsis
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Device related infection
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Gastrointestinal infection
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Infection
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Influenza
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.79%
2/254 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Meningitis
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Meningitis tuberculous
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Pharyngitis bacterial
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Pneumonia
|
2.0%
5/254 • Number of events 5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.8%
7/250 • Number of events 7 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
3.3%
8/244 • Number of events 10 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Pneumonia aspiration
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Prostate infection
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Pulmonary sepsis
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Respiratory tract infection
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Sepsis
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.6%
4/244 • Number of events 5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Septic shock
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.2%
3/244 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Subcutaneous abscess
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.80%
2/250 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Urinary tract infection
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.0%
5/244 • Number of events 5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.80%
2/250 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Vascular device infection
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Wound infection
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Anastomotic stenosis
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood calcium decreased
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Transaminases increased
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.79%
2/254 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.2%
3/254 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.80%
2/250 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.0%
5/244 • Number of events 5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.8%
7/250 • Number of events 8 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.9%
7/244 • Number of events 7 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.39%
1/254 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.80%
2/250 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.80%
2/250 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.2%
3/244 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.2%
3/250 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.82%
2/244 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.0%
5/254 • Number of events 5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.82%
2/244 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Refeeding syndrome
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.82%
2/244 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.82%
2/244 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.79%
2/254 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oncologic complication
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.80%
2/250 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Cerebral thrombosis
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Cerebral venous sinus thrombosis
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Encephalopathy
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Seizure
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Syncope
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.80%
2/250 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.2%
3/244 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Product Issues
Device dislocation
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.82%
2/244 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Psychiatric disorders
Confusional state
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Psychiatric disorders
Depression
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.6%
4/254 • Number of events 4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
3.2%
8/250 • Number of events 8 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
3.3%
8/244 • Number of events 8 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Autoimmune nephritis
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Nephritis
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Prerenal failure
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Renal failure
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.2%
3/250 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.82%
2/244 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Renal injury
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.79%
2/254 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.2%
3/254 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.80%
2/250 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.79%
2/254 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
3.2%
8/250 • Number of events 9 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.3%
13/244 • Number of events 13 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.79%
2/254 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Deep vein thrombosis
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.80%
2/250 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.2%
3/244 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Embolism
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Hypertension
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Hypotension
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Superficial vein thrombosis
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/244 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
Other adverse events
| Measure |
Pembrolizumab Monotherapy (Pembro Mono) First Course
n=254 participants at risk
Participants received pembrolizumab 200 mg IV Q3W.
|
Pembrolizumab + SOC Chemotherapy (Pembro Combo)-First Course
n=250 participants at risk
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
Placebo + SOC Chemotherapy (SOC)-First Course
n=244 participants at risk
Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
|
Pembrolizumab Monotherapy Second Course
n=4 participants at risk
Eligible participants who stopped the initial course of pembrolizumab (200 mg IV Q3W for up to 35 treatments \[approximately 2 years\]) with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (up to approximately 1 additional year).
|
Pembrolizumab + SOC Chemotherapy-Second Course
n=5 participants at risk
Eligible participants who stopped the initial course of pembrolizumab (200 mg IV Q3W for up to 35 treatments \[approximately 2 years\]) administered in combination with SOC chemotherapy, and experienced Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (up to approximately 1 additional year).
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
24.0%
61/254 • Number of events 73 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
44.8%
112/250 • Number of events 150 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
44.3%
108/244 • Number of events 144 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
75.0%
3/4 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
8.4%
21/250 • Number of events 52 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
10.7%
26/244 • Number of events 51 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.39%
1/254 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
38.0%
95/250 • Number of events 201 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
41.8%
102/244 • Number of events 222 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.79%
2/254 • Number of events 5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
10.8%
27/250 • Number of events 38 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
10.7%
26/244 • Number of events 33 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
8.8%
22/250 • Number of events 24 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
8.2%
20/244 • Number of events 20 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Hypothyroidism
|
8.3%
21/254 • Number of events 21 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.2%
28/250 • Number of events 29 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
4.1%
10/244 • Number of events 11 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.79%
2/254 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.4%
6/250 • Number of events 7 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.82%
2/244 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.1%
13/254 • Number of events 21 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
3.6%
9/250 • Number of events 11 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
4.1%
10/244 • Number of events 10 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
18.1%
46/254 • Number of events 56 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
16.4%
41/250 • Number of events 49 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
16.8%
41/244 • Number of events 54 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
20.0%
1/5 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.1%
23/254 • Number of events 26 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
9.6%
24/250 • Number of events 27 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
9.4%
23/244 • Number of events 25 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Ascites
|
2.4%
6/254 • Number of events 7 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
3.2%
8/250 • Number of events 8 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.7%
14/244 • Number of events 15 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Constipation
|
14.2%
36/254 • Number of events 43 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
28.4%
71/250 • Number of events 108 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
27.9%
68/244 • Number of events 83 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.8%
35/254 • Number of events 60 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.2%
83/250 • Number of events 153 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
29.1%
71/244 • Number of events 106 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.3%
16/254 • Number of events 18 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.2%
13/250 • Number of events 18 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
4.5%
11/244 • Number of events 13 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Dysphagia
|
4.3%
11/254 • Number of events 11 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.0%
15/250 • Number of events 17 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.6%
16/244 • Number of events 20 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.1%
8/254 • Number of events 8 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.4%
6/250 • Number of events 7 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.3%
13/244 • Number of events 14 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Nausea
|
19.3%
49/254 • Number of events 59 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
64.8%
162/250 • Number of events 295 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
52.9%
129/244 • Number of events 236 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Stomatitis
|
2.0%
5/254 • Number of events 6 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
13.2%
33/250 • Number of events 49 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
14.3%
35/244 • Number of events 39 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Vomiting
|
19.3%
49/254 • Number of events 64 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.6%
84/250 • Number of events 148 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
32.4%
79/244 • Number of events 142 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Asthenia
|
11.8%
30/254 • Number of events 33 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
16.4%
41/250 • Number of events 53 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
19.3%
47/244 • Number of events 81 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Chest pain
|
1.6%
4/254 • Number of events 6 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.6%
14/250 • Number of events 16 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.9%
7/244 • Number of events 7 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Fatigue
|
19.3%
49/254 • Number of events 63 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
42.0%
105/250 • Number of events 156 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
30.7%
75/244 • Number of events 112 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Mucosal inflammation
|
1.2%
3/254 • Number of events 5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
16.4%
41/250 • Number of events 57 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
13.9%
34/244 • Number of events 62 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Oedema peripheral
|
5.1%
13/254 • Number of events 14 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.4%
16/250 • Number of events 16 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
7.8%
19/244 • Number of events 22 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Pyrexia
|
9.8%
25/254 • Number of events 33 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.8%
32/250 • Number of events 38 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
10.2%
25/244 • Number of events 26 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Pneumonia
|
3.1%
8/254 • Number of events 8 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.2%
13/250 • Number of events 13 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.82%
2/244 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Alanine aminotransferase increased
|
5.1%
13/254 • Number of events 16 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.8%
7/250 • Number of events 8 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
3.7%
9/244 • Number of events 9 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
18/254 • Number of events 22 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
3.6%
9/250 • Number of events 10 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
4.5%
11/244 • Number of events 12 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood creatinine increased
|
3.1%
8/254 • Number of events 8 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.0%
30/250 • Number of events 52 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
13.9%
34/244 • Number of events 59 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood uric acid increased
|
0.79%
2/254 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/250 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.41%
1/244 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Neutrophil count decreased
|
1.6%
4/254 • Number of events 15 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
23.6%
59/250 • Number of events 120 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
16.4%
40/244 • Number of events 79 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Platelet count decreased
|
1.2%
3/254 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
9.2%
23/250 • Number of events 38 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
7.0%
17/244 • Number of events 21 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Weight decreased
|
11.0%
28/254 • Number of events 28 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
21.6%
54/250 • Number of events 63 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
13.5%
33/244 • Number of events 33 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
White blood cell count decreased
|
1.6%
4/254 • Number of events 6 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.0%
30/250 • Number of events 71 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
10.2%
25/244 • Number of events 52 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
18.9%
48/254 • Number of events 53 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
37.6%
94/250 • Number of events 135 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
36.9%
90/244 • Number of events 127 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.8%
7/254 • Number of events 7 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
4.4%
11/250 • Number of events 14 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.6%
16/244 • Number of events 19 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.1%
18/254 • Number of events 21 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.8%
17/250 • Number of events 21 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
9.4%
23/244 • Number of events 28 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.5%
9/254 • Number of events 10 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.6%
14/250 • Number of events 20 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.7%
14/244 • Number of events 16 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.3%
11/254 • Number of events 16 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
14.0%
35/250 • Number of events 49 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
17.2%
42/244 • Number of events 61 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
1.2%
3/254 • Number of events 11 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
13.6%
34/250 • Number of events 43 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
13.1%
32/244 • Number of events 48 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.9%
15/254 • Number of events 16 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
4.8%
12/250 • Number of events 21 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
8.2%
20/244 • Number of events 26 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.79%
2/254 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.0%
15/250 • Number of events 21 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
3.7%
9/244 • Number of events 16 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.5%
19/254 • Number of events 20 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
8.8%
22/250 • Number of events 25 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.9%
7/244 • Number of events 7 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.8%
30/254 • Number of events 32 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.2%
13/250 • Number of events 14 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.7%
14/244 • Number of events 15 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.6%
4/254 • Number of events 4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.8%
17/250 • Number of events 23 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
3.3%
8/244 • Number of events 9 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Dizziness
|
5.5%
14/254 • Number of events 18 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
8.0%
20/250 • Number of events 21 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.1%
15/244 • Number of events 22 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Dysgeusia
|
1.6%
4/254 • Number of events 4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.4%
16/250 • Number of events 18 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
8.2%
20/244 • Number of events 21 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Headache
|
6.3%
16/254 • Number of events 18 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
9.6%
24/250 • Number of events 26 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.6%
16/244 • Number of events 22 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.4%
31/250 • Number of events 36 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.6%
16/244 • Number of events 17 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.2%
3/254 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
13.6%
34/250 • Number of events 37 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.6%
16/244 • Number of events 18 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Psychiatric disorders
Insomnia
|
8.3%
21/254 • Number of events 21 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
7.2%
18/250 • Number of events 19 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
9.0%
22/244 • Number of events 24 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
20.0%
1/5 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.2%
3/250 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.82%
2/244 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.5%
19/254 • Number of events 23 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
9.6%
24/250 • Number of events 26 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
9.4%
23/244 • Number of events 26 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.2%
3/254 • Number of events 3 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
1/250 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.82%
2/244 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
20.0%
1/5 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.3%
11/254 • Number of events 16 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
7.6%
19/250 • Number of events 23 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
3.7%
9/244 • Number of events 11 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.0%
5/250 • Number of events 5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
4.1%
10/244 • Number of events 12 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
20.0%
1/5 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.39%
1/254 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.4%
16/250 • Number of events 20 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
4.9%
12/244 • Number of events 21 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.79%
2/254 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
7.6%
19/250 • Number of events 19 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
4.5%
11/244 • Number of events 11 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.4%
6/254 • Number of events 6 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.0%
15/250 • Number of events 16 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.1%
15/244 • Number of events 15 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/254 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
24.0%
60/250 • Number of events 69 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
18.9%
46/244 • Number of events 57 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/5 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.7%
22/254 • Number of events 27 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
8.4%
21/250 • Number of events 25 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
3.3%
8/244 • Number of events 11 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
20.0%
1/5 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.9%
20/254 • Number of events 23 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.4%
31/250 • Number of events 41 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.1%
15/244 • Number of events 18 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/4 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
20.0%
1/5 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Hypertension
|
4.3%
11/254 • Number of events 12 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
4.0%
10/250 • Number of events 13 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
4.9%
12/244 • Number of events 17 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
1/4 • Number of events 2 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
20.0%
1/5 • Number of events 1 • Up to approximately 78 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
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. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER